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Trial record 22 of 565 for:    applied AND irritation

To Assess the Cutaneous Irritation and Sensitization Potential of a Cosmetic Facial Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03175562
Recruitment Status : Completed
First Posted : June 5, 2017
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Basic Science
Condition Skin Care
Interventions Other: Facial micellar cleanser
Other: Saline Solution: Sodium Chloride (NaCl; 0.9%)
Enrollment 272
Recruitment Details All participants were enrolled at one center in Brazil.
Pre-assignment Details A total of 294 participants were screened,out of which 240 participants were randomized and 54 participants were not randomized. Out of 54 participants, 22 participants did not meet study criteria, 5 participants were lost to follow-up, 26 participants withdrew their consent, 1 participant was not randomized for other reasons (not specified).
Arm/Group Title All Participants
Hide Arm/Group Description Included all participants who were randomized to receive the study treatment. In this study, the test product and the negative control (saline solution) were randomly applied to 2 different cells in a single semi-occlusive patch that was applied on a subject’s dorsum.
Period Title: Overall Study
Started 240
Test Product [1] 240
Negative Control [1] 240
Completed 224
Not Completed 16
Reason Not Completed
Adverse Event             1
Lost to Follow-up             3
Withdrawal by Subject             7
Other (Not Specified)             5
[1]
All participants received both the study treatments in a single semi-occlusive patch.
Arm/Group Title Overall Participants
Hide Arm/Group Description All the participants who received any application of study products were included for baseline evaluation
Overall Number of Baseline Participants 240
Hide Baseline Analysis Population Description
Safety population (N=240), the Safety population included all participants who received any application of the study products.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 240 participants
41.2  (12.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants
Female
196
  81.7%
Male
44
  18.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
   2.1%
White
234
  97.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 3
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to treat (ITT, N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 238 238
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
2.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 5
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 238 238
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
3.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 8
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 238 238
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
4.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 10
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 238 238
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
5.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 12
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 238 238
Mean (Standard Error)
Unit of Measure: Score on scale
0  (0) 0  (0)
6.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 15
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 238 238
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
7.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 17
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 17
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 238 238
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
8.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 19
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 19
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 238 238
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
9.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase at Week 6 After 30 Minutes (Maximum 1 Hour) Post Patch Removal
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Week 6 after 30 minutes (maximum 1 hour) post patch removal
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 238 238
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
10.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase at Week 6 After 24 (±2) Hours Post Patch Removal
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Week 6 after 24 (±2) hours post patch removal
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Reference Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 238 238
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
11.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase at 6 Week 48 (±2) Hours, Post Patch Removal
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Week 6 after 48 (±2) hours post patch removal
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Reference Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 238 238
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
Time Frame Approximately 45 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description Safety population (N=240), the Safety population included all participants who received any application of the study products.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   0/240 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/240 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   6/240 (2.50%) 
Gastrointestinal disorders   
VOMITING   1/240 (0.42%) 
Infections and infestations   
INFLUENZA   3/240 (1.25%) 
TONSILLITIS BACTERIAL   1/240 (0.42%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA   1/240 (0.42%) 
MYALGIA   1/240 (0.42%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03175562     History of Changes
Other Study ID Numbers: 207585
First Submitted: June 1, 2017
First Posted: June 5, 2017
Results First Submitted: May 1, 2018
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019