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Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03441789
Recruitment Status : Completed
First Posted : February 22, 2018
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
L.H. Kircik, M.D., Derm Research, PLLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: Enstilar
Drug: Vehicle
Drug: Otezla
Enrollment 28
Recruitment Details  
Pre-assignment Details 1 participant signed consent but failed screening
Arm/Group Title Otezla Plus Enstilar Foam Otezla Plus Vehicle Foam
Hide Arm/Group Description

Subjects randomized to this group will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily

Enstilar: Enstilar foam applied to affected areas daily

Otezla: Otezla 30mg

Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily

Vehicle: vehicle foam applied to affected areas once daily

Otezla: Otezla 30mg

Period Title: Overall Study
Started 14 14
Completed 13 10
Not Completed 1 4
Reason Not Completed
Withdrawal by Subject             1             1
Adverse Event             0             1
Protocol Violation             0             1
Lost to Follow-up             0             1
Arm/Group Title Otezla Plus Enstilar Foam Otezla Plus Vehicle Foam Total
Hide Arm/Group Description

Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily

Enstilar: Enstilar foam applied to affected areas daily

Otezla: Otezla 30mg

Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily

Vehicle: vehicle foam applied to affected areas once daily

Otezla: Otezla 30mg

Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
55  (17) 52  (12) 53  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
4
  28.6%
5
  35.7%
9
  32.1%
Male
10
  71.4%
9
  64.3%
19
  67.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
14
 100.0%
14
 100.0%
28
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 14 participants 28 participants
14 14 28
1.Primary Outcome
Title Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16
Hide Description PASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) The body is divided into 4 sections: head (10% of total body surface area,) arms (20%,) trunk(30%,) and legs (40%.) Each of these is scored by itself and the 4 scores then combined to obtain thePASI. For each body area, the percent of skin area involved is estimated and graded based on this value (0=0% of area involved, 1=<10%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%.) Within each area, the severity of disease is based on 3 clinical signs: erythema or redness, induration or thickness, and desquamation or scaliness. Each is graded on a scale from 0(none) to 4(maximum.) The sum of all 3 parameters is calculated for each body section, multiplied by the area score for that section and then multiplied by the weight of that section (.1for head, .2 arms, .3 trunk and .4 legs)
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Otezla Plus Enstilar Foam Otezla Plus Vehicle Foam
Hide Arm/Group Description:

Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily

Enstilar: Enstilar foam applied to affected areas daily

Otezla: Otezla 30mg

Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily

Vehicle: vehicle foam applied to affected areas once daily

Otezla: Otezla 30mg

Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
7
  50.0%
2
  14.3%
2.Secondary Outcome
Title Percent of Subjects With PASI 75 at Week 4 and Week 12
Hide Description Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.)
Time Frame 4 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Otezla Plus Enstilar Foam Otezla Plus Vehicle Foam
Hide Arm/Group Description:

Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily

Enstilar: Enstilar foam applied to affected areas daily

Otezla: Otezla 30mg

Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily

Vehicle: vehicle foam applied to affected areas once daily

Otezla: Otezla 30mg

Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
week 4
7
  50.0%
1
   7.1%
week 12
4
  28.6%
2
  14.3%
3.Secondary Outcome
Title Percent of Subjects With PASI 90 and 100 at Week 16
Hide Description Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.)
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Otezla Plus Enstilar Foam Otezla Plus Vehicle Foam
Hide Arm/Group Description:

Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily

Enstilar: Enstilar foam applied to affected areas daily

Otezla: Otezla 30mg

Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily

Vehicle: vehicle foam applied to affected areas once daily

Otezla: Otezla 30mg

Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
PASI 90
4
  28.6%
2
  14.3%
PASI 100
1
   7.1%
0
   0.0%
4.Secondary Outcome
Title Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
Hide Description The Investigator will rate the severity of of disease based on the assessment of 3 clinical signs (erythema, induration, desquamation) wherein 0=no signs of psoriasis, 1=almost clear, 2=mild, 3=moderate, 4=severe
Time Frame 4 weeks, 12 weeks, 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Otezla Plus Enstilar Foam Otezla Plus Vehicle Foam
Hide Arm/Group Description:

Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily

Enstilar: Enstilar foam applied to affected areas daily

Otezla: Otezla 30mg

Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily

Vehicle: vehicle foam applied to affected areas once daily

Otezla: Otezla 30mg

Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
week 4 clear
1
   7.1%
0
   0.0%
almost clear
5
  35.7%
1
   7.1%
mild
7
  50.0%
4
  28.6%
moderate
1
   7.1%
9
  64.3%
severe
0
   0.0%
0
   0.0%
week 12 clear
1
   7.1%
0
   0.0%
almost clear
1
   7.1%
3
  21.4%
mild
5
  35.7%
4
  28.6%
moderate
6
  42.9%
7
  50.0%
severe
1
   7.1%
0
   0.0%
week 16 clear
1
   7.1%
1
   7.1%
almost clear
8
  57.1%
1
   7.1%
mild
4
  28.6%
3
  21.4%
moderate
0
   0.0%
9
  64.3%
severe
1
   7.1%
0
   0.0%
5.Secondary Outcome
Title Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16
Hide Description The Itch VAS (Visual Analog Scale) is completed by subjects wherein they are asked to rate the severity of their itching over the last 48 hours on a scale from 0 (no itching) to 10 (unbearable itching); low scores indicate a better outcome.
Time Frame 4 weeks, 12 weeks, 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Otezla Plus Enstilar Foam Otezla Plus Vehicle Foam
Hide Arm/Group Description:

Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily

Enstilar: Enstilar foam applied to affected areas daily

Otezla: Otezla 30mg

Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily

Vehicle: vehicle foam applied to affected areas once daily

Otezla: Otezla 30mg

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: scale unit
week 4 2  (2) 5  (3)
week 12 4  (3) 4  (3)
week 16 3  (3) 4  (3)
6.Secondary Outcome
Title Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16
Hide Description The DLQI is a 10-question tool completed by subjects to ascertain the severity of disease based on the extent to which disease interferes with daily life. Each question is scored according to the response wherein Very Much =3, A lot=2, A little=1 and Not at all=0. The sum of all responses is then recorded on a scale from 0 to 30, lower scores indicating better quality of life.
Time Frame 4 weeks, 12, weeks, 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Otezla Plus Enstilar Foam Otezla Plus Vehicle Foam
Hide Arm/Group Description:

Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily

Enstilar: Enstilar foam applied to affected areas daily

Otezla: Otezla 30mg

Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily

Vehicle: vehicle foam applied to affected areas once daily

Otezla: Otezla 30mg

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
week 4 2  (2) 5  (4)
week 12 5  (5) 5  (4)
week 16 3  (4) 6  (6)
Time Frame screening to week 16
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Otezla Plus Enstilar Foam Otezla Plus Vehicle Foam
Hide Arm/Group Description

Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily

Enstilar: Enstilar foam applied to affected areas daily

Otezla: Otezla 30mg

Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily

Vehicle: vehicle foam applied to affected areas once daily

Otezla: Otezla 30mg

All-Cause Mortality
Otezla Plus Enstilar Foam Otezla Plus Vehicle Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Otezla Plus Enstilar Foam Otezla Plus Vehicle Foam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      0/14 (0.00%)    
Blood and lymphatic system disorders     
thrombocytopenia   1/14 (7.14%)  1 0/14 (0.00%)  0
Cardiac disorders     
sinus tachycardia   1/14 (7.14%)  1 0/14 (0.00%)  0
Infections and infestations     
upper respiratory infection   1/14 (7.14%)  1 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
chronic obstructive pulmonary disease exacerbation   1/14 (7.14%)  1 0/14 (0.00%)  0
shortness of air   1/14 (7.14%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Otezla Plus Enstilar Foam Otezla Plus Vehicle Foam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/14 (35.71%)      9/14 (64.29%)    
Cardiac disorders     
hypertension   0/14 (0.00%)  0 1/14 (7.14%)  1
persistent lower extremity edema   0/14 (0.00%)  0 1/14 (7.14%)  1
Gastrointestinal disorders     
diarrhea   1/14 (7.14%)  1 0/14 (0.00%)  0
abdominal cramping   1/14 (7.14%)  1 0/14 (0.00%)  0
General disorders     
fall at home   1/14 (7.14%)  1 0/14 (0.00%)  0
right flank pain   1/14 (7.14%)  1 0/14 (0.00%)  0
nausea   1/14 (7.14%)  1 1/14 (7.14%)  1
right lower jaw pain   0/14 (0.00%)  0 1/14 (7.14%)  1
frequent muscle fasciculation right lower eyelid   0/14 (0.00%)  0 1/14 (7.14%)  1
sensation of fullness in neck   0/14 (0.00%)  0 1/14 (7.14%)  1
headache   0/14 (0.00%)  0 1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders     
increased joint pain generalized   1/14 (7.14%)  1 1/14 (7.14%)  1
compressed lumbar disc   0/14 (0.00%)  0 1/14 (7.14%)  1
right ankle pain   0/14 (0.00%)  0 1/14 (7.14%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
squamous cell carcinoma  [1]  1/14 (7.14%)  1 0/14 (0.00%)  0
Renal and urinary disorders     
overactive bladder   1/14 (7.14%)  1 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
rhinorrhea   2/14 (14.29%)  2 0/14 (0.00%)  0
chest congestion   1/14 (7.14%)  1 0/14 (0.00%)  0
dyspnea at rest   1/14 (7.14%)  1 0/14 (0.00%)  0
upper respiratory infection   1/14 (7.14%)  1 2/14 (14.29%)  2
dry cough   0/14 (0.00%)  0 1/14 (7.14%)  1
bronchitis   0/14 (0.00%)  0 1/14 (7.14%)  1
Skin and subcutaneous tissue disorders     
intertrigo   0/14 (0.00%)  0 1/14 (7.14%)  1
abrasion right shin   0/14 (0.00%)  0 1/14 (7.14%)  1
generalized rash   0/14 (0.00%)  0 1/14 (7.14%)  1
Surgical and medical procedures     
root canal   0/14 (0.00%)  0 1/14 (7.14%)  1
Indicates events were collected by systematic assessment
[1]
right upper arm
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: M. McAllister
Organization: Skin Sciences, PLLC
Phone: 5024519000
EMail: mmdermresearch@yahoo.com
Layout table for additonal information
Responsible Party: L.H. Kircik, M.D., Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT03441789     History of Changes
Other Study ID Numbers: ENS-1701
First Submitted: February 1, 2018
First Posted: February 22, 2018
Results First Submitted: February 11, 2019
Results First Posted: March 13, 2019
Last Update Posted: March 13, 2019