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Assessment of the Human Systemic Absorption of Sunscreen Ingredients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03582215
Recruitment Status : Completed
First Posted : July 10, 2018
Results First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
Spaulding Clinical Research LLC
Information provided by (Responsible Party):
Food and Drug Administration (FDA)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Systemic Exposure to Sunscreen Ingredients
Interventions Drug: Part 1: Cream
Drug: Part 1: Lotion
Drug: Part 1: Spray 1
Drug: Part 1: Spray 2
Drug: Part 2: Lotion
Drug: Part 2: Aerosol Spray
Drug: Part 2: Nonaerosol Spray
Drug: Part 2: Pump Spray
Enrollment 72
Recruitment Details  
Pre-assignment Details Equal allocation of men and women for each treatment arm.
Arm/Group Title Part 1: Cream Part 1: Lotion Part 1: Spray 1 Part 1: Spray 2 Part 2: Lotion Part 2: Aerosol Spray Part 2: Nonaerosol Spray Part 2: Pump Spray
Hide Arm/Group Description

Part 1: Cream:

Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Lotion:

Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Spray 1:

Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Spray 2:

Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 2: Lotion:

Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene

One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Aerosol Spray:

Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Nonaerosol Spray:

Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Pump Spray:

Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Period Title: Overall Study
Started 6 6 6 6 12 12 12 12
Completed 5 6 6 6 12 12 10 10
Not Completed 1 0 0 0 0 0 2 2
Reason Not Completed
Adverse Event             1             0             0             0             0             0             2             2
Arm/Group Title Part 1: Cream Part 1: Lotion Part 1: Spray 1 Part 1: Spray 2 Part 2: Lotion Part 2: Aerosol Spray Part 2: Nonaerosol Spray Part 2: Pump Spray Total
Hide Arm/Group Description

Part 1: Cream

Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Lotion

Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Spray 1

Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Spray 2

Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 2: Lotion

Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene

One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.

Part 2: Sunscreen Product #1, 2, 3 or 4: Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Aerosol Spray

Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Nonaerosol Spray

Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Pump Spray

Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 12 12 12 12 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 12 participants 12 participants 12 participants 12 participants 72 participants
31.2  (10.8) 34.5  (6.9) 42.8  (13.0) 33.7  (9.1) 45.1  (13.8) 41.4  (13.4) 39.2  (12.2) 29.0  (8.5) 37.6  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 12 participants 12 participants 12 participants 12 participants 72 participants
Female
3
  50.0%
3
  50.0%
3
  50.0%
3
  50.0%
6
  50.0%
6
  50.0%
6
  50.0%
6
  50.0%
36
  50.0%
Male
3
  50.0%
3
  50.0%
3
  50.0%
3
  50.0%
6
  50.0%
6
  50.0%
6
  50.0%
6
  50.0%
36
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 12 participants 12 participants 12 participants 12 participants 72 participants
Hispanic or Latino
1
  16.7%
1
  16.7%
2
  33.3%
0
   0.0%
1
   8.3%
1
   8.3%
0
   0.0%
1
   8.3%
7
   9.7%
Not Hispanic or Latino
5
  83.3%
5
  83.3%
4
  66.7%
6
 100.0%
11
  91.7%
11
  91.7%
12
 100.0%
11
  91.7%
65
  90.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 12 participants 12 participants 12 participants 12 participants 72 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
2
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  83.3%
4
  66.7%
1
  16.7%
4
  66.7%
4
  33.3%
5
  41.7%
4
  33.3%
10
  83.3%
37
  51.4%
White
0
   0.0%
2
  33.3%
5
  83.3%
2
  33.3%
8
  66.7%
7
  58.3%
6
  50.0%
2
  16.7%
32
  44.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
1
   1.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 6 participants 6 participants 12 participants 12 participants 12 participants 12 participants 72 participants
6 6 6 6 12 12 12 12 72
Body mass index (kg/m2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 6 participants 6 participants 6 participants 6 participants 12 participants 12 participants 12 participants 12 participants 72 participants
26.7  (2.8) 25.4  (2.5) 24.1  (3.2) 24.0  (3.0) 26.2  (2.2) 25.8  (3.7) 25.8  (2.4) 26.0  (3.3) 25.7  (2.9)
Fitzpatrick Skin Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 12 participants 12 participants 12 participants 12 participants 72 participants
I 0 0 0 0 0 0 0 0 0
II 0 0 1 0 3 2 3 1 10
III 0 1 3 1 5 10 6 9 35
IV 0 3 0 1 4 0 3 2 13
V 3 2 1 2 0 0 0 0 8
VI 3 0 1 2 0 0 0 0 6
[1]
Measure Description: Type I - highly sensitive, always burns, never tans (e.g. Red hair with freckles); Type II - Very sun sensitive, burns easily, tans minimally (e.g. Fair skinned, fair haired Caucasians); Type III - Sun sensitive skin, sometimes burns, slows tans to light brown (e.g. Darker Caucasians); Type IV - Minimally sun sensitive, burns minimally, always tans to moderate brown (e.g. Mediterranean type Caucasians, some Hispanics); Type V - Sun insensitive skin, rarely burns, tans well (e.g. Some Hispanics, some Blacks); and Type VI - Sun insensitive, never burns, deeply pigmented (e.g. Darker Blacks).
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 6 participants 6 participants 6 participants 6 participants 12 participants 12 participants 12 participants 12 participants 72 participants
77.6  (10.4) 73.2  (17.3) 70.9  (9.9) 69.1  (12.5) 76.3  (10.8) 76.0  (15.6) 72.0  (8.9) 75.5  (12.9) 74.2  (12.1)
Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 6 participants 6 participants 6 participants 6 participants 12 participants 12 participants 12 participants 12 participants 72 participants
170.7  (9.9) 168.4  (15.5) 70.9  (9.9) 171.7  (6.0) 170.3  (9.7) 171.0  (11.0) 167.0  (9.3) 170.2  (11.1) 169.8  (10.0)
Body surface area (m^2)  
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 6 participants 6 participants 6 participants 6 participants 12 participants 12 participants 12 participants 12 participants 72 participants
1.9  (0.2) 1.8  (0.3) 1.8  (0.1) 1.8  (0.2) 1.9  (0.2) 1.9  (0.2) 1.8  (0.2) 1.9  (0.2) 1.9  (0.2)
1.Primary Outcome
Title Avobenzone Maximum Concentration
Hide Description Maximum concentration (observed peak drug concentration) (Cmax)
Time Frame 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, and 144 h for Part 1; same time points and 216, 312, and 480 h for Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one application and had at least one pharmacokinetic sample
Arm/Group Title Part 1: Cream Part 1: Lotion Part 1: Spray 1 Part 1: Spray 2 Part 2: Lotion Part 2: Aerosol Spray Part 2: Nonaerosol Spray Part 2: Pump Spray
Hide Arm/Group Description:

Part 1: Cream:

Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Lotion:

Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Spray 1:

Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Spray 2:

Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 2: Lotion:

Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene

One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Aerosol Spray:

Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Nonaerosol Spray:

Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Pump Spray:

Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Overall Number of Participants Analyzed 6 6 6 6 12 12 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1.8
(32%)
4.3
(46%)
4.0
(61%)
3.4
(77%)
7.1
(74%)
3.5
(71%)
3.5
(73%)
3.3
(48%)
2.Secondary Outcome
Title Oxybenzone Maximum Concentration
Hide Description Maximum concentration (observed peak drug concentration) (Cmax)
Time Frame 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, and 144 h for Part 1; same time points and 216, 312, and 480 h for Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, cream and for Part 2, nonaerosol spray and pump spray products did not contain oxybenzone and were excluded from the analysis.
Arm/Group Title Part 1: Lotion Part 1: Spray 1 Part 1: Spray 2 Part 2: Lotion Part 2: Aerosol Spray
Hide Arm/Group Description:

Part 1: Lotion:

Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Spray 1:

Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Spray 2:

Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 2: Lotion:

Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene

One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Aerosol Spray:

Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Overall Number of Participants Analyzed 6 6 6 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
169.3
(45%)
209.6
(67%)
194.9
(52%)
258.1
(53%)
180.1
(57%)
3.Secondary Outcome
Title Octocrylene Maximum Concentration
Hide Description Maximum concentration (observed peak drug concentration) (Cmax)
Time Frame 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, and 144 h for Part 1; same time points and 216, 312, and 480 h for Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 2, pump spray product did not contain octocrylene and was excluded from the analysis.
Arm/Group Title Part 1: Cream Part 1: Lotion Part 1: Spray 1 Part 1: Spray 2 Part 2: Lotion Part 2: Aerosol Spray Part 2: Nonaerosol Spray
Hide Arm/Group Description:

Part 1: Cream:

Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Lotion:

Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Spray 1:

Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Spray 2:

Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 2: Lotion:

Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene

One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Aerosol Spray:

Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Nonaerosol Spray:

Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Overall Number of Participants Analyzed 6 6 6 6 12 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
5.7
(47%)
5.7
(66%)
2.9
(102%)
7.8
(113%)
7.8
(87%)
6.6
(78%)
6.6
(104%)
4.Secondary Outcome
Title Ecamsule Maximum Concentration
Hide Description Maximum concentration (observed peak drug concentration) (Cmax)
Time Frame 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, and 144 h for Part 1
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, lotion, spray 1, and spray 2 and for Part 2, lotion, aerosol spray, nonaerosol spray, and pump spray did not contain ecamsule and were excluded from the analysis.
Arm/Group Title Part 1: Cream
Hide Arm/Group Description:

Part 1: Cream:

Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1.5
(166%)
5.Secondary Outcome
Title Homosalate Maximum Concentration
Hide Description Maximum concentration (observed peak drug concentration) (Cmax)
Time Frame 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, 144, 216, 312, and 480 h for Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, cream, lotion, and spray 2 and for Part 2, lotion did not contain homosalate and were excluded from the analysis.
Arm/Group Title Part 1: Spray 1 Part 2: Aerosol Spray Part 2: Nonaerosol Spray Part 2: Pump Spray
Hide Arm/Group Description:

Part 1: Spray 1:

Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 2: Aerosol Spray:

Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Nonaerosol Spray:

Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Pump Spray:

Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Overall Number of Participants Analyzed 6 12 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
40.3
(74%)
23.1
(68%)
17.9
(62%)
13.9
(70%)
6.Secondary Outcome
Title Octisalate Maximum Concentration
Hide Description Maximum concentration (observed peak drug concentration) (Cmax)
Time Frame 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, 144, 216, 312, and 480 h for Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, cream, lotion, and spray 2 and for Part 2, lotion did not contain octisalate and were excluded from the analysis.
Arm/Group Title Part 1: Spray 1 Part 2: Aerosol Spray Part 2: Nonaerosol Spray Part 2: Pump Spray
Hide Arm/Group Description:

Part 1: Spray 1:

Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 2: Aerosol Spray:

Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Nonaerosol Spray:

Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Pump Spray:

Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Overall Number of Participants Analyzed 6 12 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
10.0
(46%)
5.1
(82%)
5.8
(77%)
4.6
(98%)
7.Secondary Outcome
Title Octinoxate Maximum Concentration
Hide Description Maximum concentration (observed peak drug concentration) (Cmax)
Time Frame 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, 144, 216, 312, and 480 h for Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, octinoxate was not analyzed for cream, lotion, spray 1, and spray 2 and all products were excluded from the analysis. For Part 2, lotion and aerosol spray did not contain octinoxate and were excluded from the analysis.
Arm/Group Title Part 2: Nonaerosol Spray Part 2: Pump Spray
Hide Arm/Group Description:

Part 2: Nonaerosol Spray:

Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Pump Spray:

Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Overall Number of Participants Analyzed 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
7.9
(87%)
5.2
(68%)
Time Frame 7 days for part 1; 21 days for part 2
Adverse Event Reporting Description MedDRA
 
Arm/Group Title Part 1: Cream Part 1: Lotion Part 1: Spray 1 Part 1: Spray 2 Part 2: Lotion Part 2: Aerosol Spray Part 2: Nonaerosol Spray Part 2: Pump Spray
Hide Arm/Group Description

Part 1: Cream

Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Lotion

Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Spray 1

Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 1: Spray 2

Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

Part 2: Lotion

Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Aerosol Spray

Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Nonaerosol Spray

Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Part 2: Pump Spray

Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

All-Cause Mortality
Part 1: Cream Part 1: Lotion Part 1: Spray 1 Part 1: Spray 2 Part 2: Lotion Part 2: Aerosol Spray Part 2: Nonaerosol Spray Part 2: Pump Spray
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/12 (0.00%)      0/12 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Hide Serious Adverse Events
Part 1: Cream Part 1: Lotion Part 1: Spray 1 Part 1: Spray 2 Part 2: Lotion Part 2: Aerosol Spray Part 2: Nonaerosol Spray Part 2: Pump Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/12 (0.00%)      0/12 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part 1: Cream Part 1: Lotion Part 1: Spray 1 Part 1: Spray 2 Part 2: Lotion Part 2: Aerosol Spray Part 2: Nonaerosol Spray Part 2: Pump Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/6 (66.67%)      3/6 (50.00%)      1/6 (16.67%)      2/6 (33.33%)      6/12 (50.00%)      9/12 (75.00%)      11/12 (91.67%)      5/12 (41.67%)    
Ear and labyrinth disorders                 
Ear pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Eye disorders                 
Eye burning  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Eye irritation  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 2/12 (16.67%)  4 1/12 (8.33%)  1 1/12 (8.33%)  1
Eye pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Ocular hyperaemia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  1 0/12 (0.00%)  0
Gastrointestinal disorders                 
Abodinal Pain  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Chapped lips  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Diarrhea  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Lip swelling  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Oropharyngeal pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
General disorders                 
Fatigue  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Burning sensation  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Tenderness  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Vessel puncture site bruise  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  1 1/12 (8.33%)  1 0/12 (0.00%)  0
Vessel puncture site haematoma  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Vessel puncture site pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  1 0/12 (0.00%)  0
Vessel puncture site reaction  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Vessel punctue site swelling  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Neck pain  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Nervous system disorders                 
Dizziness  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Headache  1  0/6 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 2/12 (16.67%)  2 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Paraesthesia  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Hyperaesthesia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Cough  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Nasal congestion  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Rhinorrhoea  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  1 0/12 (0.00%)  0
Sneezing  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders                 
Milia  1  1/6 (16.67%)  4 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Pruritus  1  1/6 (16.67%)  1 1/6 (16.67%)  4 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 2/12 (16.67%)  2
Rash  1  1/6 (16.67%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1 1/6 (16.67%)  2 1/12 (8.33%)  1 6/12 (50.00%)  7 5/12 (41.67%)  11 2/12 (16.67%)  7
Application site erythema  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/12 (16.67%)  2 0/12 (0.00%)  0 3/12 (25.00%)  5 0/12 (0.00%)  0
Erythema  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/12 (16.67%)  4 0/12 (0.00%)  0 1/12 (8.33%)  2 0/12 (0.00%)  0
Pain of skin  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  2
Skin abrasion  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  1
Skin disorder  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Skin irritation  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  2 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Vascular disorders                 
Haematoma  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
The study was conducted in indoor conditions and was not designed to assess differences by formulation or participant factors.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Strauss, MD, PhD
Organization: U.S. Food and Drug Administration
Phone: 301-796-6323
EMail: David.strauss@fda.hhs.gov
Layout table for additonal information
Responsible Party: Food and Drug Administration (FDA)
ClinicalTrials.gov Identifier: NCT03582215    
Other Study ID Numbers: SCR-005
First Submitted: June 27, 2018
First Posted: July 10, 2018
Results First Submitted: February 11, 2020
Results First Posted: April 21, 2020
Last Update Posted: April 21, 2020