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Human Comedogenicity Test

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: NCT03428997
Recruitment Status : Completed
First Posted : February 12, 2018
Results First Posted : August 2, 2019
Last Update Posted : July 3, 2023
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Other
Condition Comedogenicity
Interventions Device: Lotion
Other: Negative Control
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lotion and Negative Control
Hide Arm/Group Description The Formulation Lotion F#13541-131 on an occlusive patch and the undosed occlusive patch (negative control) were each applied to a test site on each subject's back three times a week for four weeks.
Period Title: Overall Study
Started 24
Completed 16
Not Completed 8
Reason Not Completed
Sponsor decision.             1
Withdrawal by Subject             3
Lost to Follow-up             4
Arm/Group Title Lotion and Negative Control
Hide Arm/Group Description The Formulation Lotion F#13541-131 on an occlusive patch and the undosed occlusive patch (negative control) were each applied to a test site on each subject's back three times a week for four weeks.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
Only subjects that completed the study per-protocol are included in the analysis.Each subject had each treatment patched on their back
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
36.8  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
10
  62.5%
Male
6
  37.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Hispanic or Latino
4
  25.0%
Not Hispanic or Latino
12
  75.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   6.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
9
  56.3%
White
6
  37.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Microcomedone Score of Follicular Biopsies
Hide Description

Grades for irritations/reactions were The following 5-point global assessment scale was used to grade the follicular biopsies for microcomedones: 0 None (0% No microcomedones) 0.5 Slight (1-24% Smallish horny masses)

  1. Mild (25-49% Smallish horny masses)
  2. Moderate (50-74% Moderately sized horny masses)
  3. Severe (75-100% Larger globoid microcomedones)
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants received both the test product and a negative control following a randomization.
Arm/Group Title Lotion Negative Control
Hide Arm/Group Description:
The Formulation Lotion F#13541-131 on an occlusive patch was applied to a test site on each subject's back three times a week for four weeks.
Undosed occlusive patch (negative control) was applied to a test site on each subject's back three times a week for four weeks.
Overall Number of Participants Analyzed 16 16
Overall Number of Units Analyzed
Type of Units Analyzed: Test Site
 16 16
Mean (Standard Deviation)
Unit of Measure: microcomedone score
0.84  (0.51) 0.97  (0.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lotion
Comments Testing hypothesis is that the mean score is equal between the compared treatments.
Type of Statistical Test Equivalence
Comments Mixed-effects model, where the test material/negative control is a fixed effect and the subject is a random effect
Statistical Test of Hypothesis P-Value 0.274
Comments [Not Specified]
Method 2-sided t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments [Not Specified]
Time Frame 8 weeks
Adverse Event Reporting Description All of the Adverse Events recorded during the study were related to test material sites.
 
Arm/Group Title Lotion Negative Control
Hide Arm/Group Description The Formulation Lotion F#13541-131 on an occlusive patch was applied to a test site on each subject's back three times a week for four weeks. The undosed occlusive patch (negative control) was applied to a test site on each subjects back three times a week for four weeks.
All-Cause Mortality
Lotion Negative Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/24 (0.00%)    
Hide Serious Adverse Events
Lotion Negative Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Lotion Negative Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/24 (16.67%)      0/24 (0.00%)    
Skin and subcutaneous tissue disorders     
Erythema †  4/24 (16.67%)  4 0/24 (0.00%)  0
Cracking/Fissures/Dryness/Scabbing †  3/24 (12.50%)  3 0/24 (0.00%)  0
Edema †  2/24 (8.33%)  2 0/24 (0.00%)  0
Papule †  1/24 (4.17%)  1 0/24 (0.00%)  0
Pustule †  1/24 (4.17%)  1 0/24 (0.00%)  0
Vessicles †  1/24 (4.17%)  1 0/24 (0.00%)  0
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
The Principal Investigator (PI) will provide Sponsor with at least sixty (60) days to review any Publication. No Publication that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written consent. If requested in writing, the PI withholds such Publication for up to an additional sixty (60) days to allow for filing of a patent application.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Heather Smith
Organization: Johnson & Johnson Consumer Inc.
Phone: (908) 874-1235
EMail: HSmith21@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )
ClinicalTrials.gov Identifier: NCT03428997    
Other Study ID Numbers: CO-171106085430-SACT
First Submitted: January 19, 2018
First Posted: February 12, 2018
Results First Submitted: January 25, 2019
Results First Posted: August 2, 2019
Last Update Posted: July 3, 2023