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Trial record 35 of 568 for:    applied AND irritation

To Investigate Primary Irritation Potential of Four Skin Serum Products on Human Subjects Assessed by 24 Hour Patch 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: NCT03233009
Recruitment Status : Completed
First Posted : July 28, 2017
Results First Posted : September 7, 2018
Last Update Posted : January 16, 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: Experimental Daily Defense Serum A
Other: Experimental Daily Defense Serum C
Other: Experimental Daily Defense Serum G
Other: Experimental Daily Defense Serum N
Other: Saline Solution Sodium Chloride
Enrollment 43
Recruitment Details All the participants were enrolled at one center in Brazil.
Pre-assignment Details A total of 46 participants were screened, out of which 3 participants did not meet study criteria, 43 participants were enrolled in the study out of which 3 participants withdrew their consent. Remaining 40 participants were randomized to the study.
Arm/Group Title Overall Participants
Hide Arm/Group Description All participants enrolled in the study received all the study products. Test and control products were applied to a paper disc (or cell) contained within an adhesive patch in a randomized manner. The number of cells available on the patch test tape is 6 (but only 5 cells were used, 4 test and 1 reference products). The patch was then applied onto the dorsum (scapula region) of each participant for a period of 24 ± 2 hours, the sequence of the product application to the cells was as per the randomization schedule.
Period Title: Overall Study
Started 40
Test Product 1 39
Test Product 2 39
Test Product 3 39
Test Product 4 39
Reference Product 39
Completed [1] 39
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
[1]
1 participant lost to follow-up was removed from all the treatment arms.
Arm/Group Title Overall Participants
Hide Arm/Group Description All participants randomized to the study. Test and control products were applied to a paper disc (or cell) contained within an adhesive patch. The number of cells available on the patch test tape is 6 (but only 5 cells were used, 4 test and 1 reference products). The patch was then applied onto the dorsum (scapula region) of each participant for a period of 24 ± 2 hours, the sequence of the product application to the cells was as per the randomization schedule.
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
Baseline population reflects the safety population. The safety population (N= 40) included all participants who received any of the test products
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
35.7  (11.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
33
  82.5%
Male
7
  17.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
  27.5%
White
29
  72.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal
Hide Description Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; 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.
Time Frame At Day 2 (15-30 minutes post patch removal)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 39) 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 1 Test Product 2 Test Product 3 Test Product 4 Reference Product
Hide Arm/Group Description:
This arm includes data from the test sites where test product 1 was applied.
This arm includes data from the test sites where test product 2 was applied.
This arm includes data from the test sites where test product 3 was applied.
This arm includes data from the test sites where test product 4 was applied.
This arm includes data from the test sites where reference product was applied.
Overall Number of Participants Analyzed 39 39 39 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
39
 100.0%
39
 100.0%
39
 100.0%
39
 100.0%
39
 100.0%
1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Frequency of Dermal Response Score at 24 Hours Post Patch Removal
Hide Description Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; 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.
Time Frame At Day 3 (24 hours post patch removal)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 39) 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 1 Test Product 2 Test Product 3 Test Product 4 Reference Product
Hide Arm/Group Description:
This arm includes data from the test sites where test product 1 was applied.
This arm includes data from the test sites where test product 2 was applied.
This arm includes data from the test sites where test product 3 was applied.
This arm includes data from the test sites where test product 4 was applied.
This arm includes data from the test sites where reference product was applied.
Overall Number of Participants Analyzed 39 39 39 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
39
 100.0%
39
 100.0%
39
 100.0%
39
 100.0%
39
 100.0%
1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Frequency of Dermal Response Score at 48 Hours Post Patch Removal
Hide Description Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; 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.
Time Frame At Day 4 (48 hours post patch removal)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 39) 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 1 Test Product 2 Test Product 3 Test Product 4 Reference Product
Hide Arm/Group Description:
This arm includes data from the test sites where test product 1 was applied.
This arm includes data from the test sites where test product 2 was applied.
This arm includes data from the test sites where test product 3 was applied.
This arm includes data from the test sites where test product 4 was applied.
This arm includes data from the test sites where reference product was applied.
Overall Number of Participants Analyzed 39 39 39 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
39
 100.0%
39
 100.0%
39
 100.0%
39
 100.0%
39
 100.0%
1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Average Dermal Response Score at 30 Minutes Post Patch Removal
Hide Description Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; 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.
Time Frame At Day 2 (15-30 minutes post patch removal)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 39) 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 1 Test Product 2 Test Product 3 Test Product 4 Reference Product
Hide Arm/Group Description:
This arm includes data from the test sites where test product 1 was applied.
This arm includes data from the test sites where test product 2 was applied.
This arm includes data from the test sites where test product 3 was applied.
This arm includes data from the test sites where test product 4 was applied.
This arm includes data from the test sites where reference product was applied.
Overall Number of Participants Analyzed 39 39 39 39 39
Mean (Standard Deviation)
Unit of Measure: Score on Scale
0  (0) 0  (0) 0  (0) 0  (0) 0  (0)
5.Primary Outcome
Title Average Dermal Response Score at 24 Hours Post Patch Removal
Hide Description Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; 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.
Time Frame At Day 3 (24 hours post patch removal)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 39) 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 1 Test Product 2 Test Product 3 Test Product 4 Reference Product
Hide Arm/Group Description:
This arm includes data from the test sites where test product 1 was applied.
This arm includes data from the test sites where test product 2 was applied.
This arm includes data from the test sites where test product 3 was applied.
This arm includes data from the test sites where test product 4 was applied.
This arm includes data from the test sites where reference product was applied.
Overall Number of Participants Analyzed 39 39 39 39 39
Mean (Standard Deviation)
Unit of Measure: Score on Scale
0  (0) 0  (0) 0  (0) 0  (0) 0  (0)
6.Primary Outcome
Title Average Dermal Response Score at 48 Hours Post Patch Removal
Hide Description Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; 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.
Time Frame At Day 4 (48 hours post patch removal)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 39) 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 1 Test Product 2 Test Product 3 Test Product 4 Reference Product
Hide Arm/Group Description:
This arm includes data from the test sites where test product 1 was applied.
This arm includes data from the test sites where test product 2 was applied.
This arm includes data from the test sites where test product 3 was applied.
This arm includes data from the test sites where test product 4 was applied.
This arm includes data from the test sites where reference product was applied.
Overall Number of Participants Analyzed 39 39 39 39 39
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0) 0  (0) 0  (0) 0  (0)
7.Secondary Outcome
Title Number of Participants With Combined Skin Irritation (Dermal Response) Scores at 30 Minutes, 24 Hours and 48 Hours Post Patch Removal
Hide Description A trained assessor assessed all patch sites.Following scores were used to express response observed at 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:GradeA/Score0=Slight glazed appearance,GradeB/Score1=Marked glazing,GradeC/Score2=Glazing with peeling and cracking,GradeF/Score3=Glazing with fissures,Grade G/Score 3=Film of dried serous exudate covering all or portion of patch,Grade H/Score3=Small petechial erosions and/or scabs.The letter grades were converted to scores.Superficial irritation scores were only provided if there was a dermal response score >0.No effect is 0 score(i.e. no evidence).Full Range 0-10.Lower score indicates better product tolerabily
Time Frame At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 39) 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 1 Test Product 2 Test Product 3 Test Product 4 Reference Product
Hide Arm/Group Description:
This arm includes data from the test sites where test product 1 was applied.
This arm includes data from the test sites where test product 2 was applied.
This arm includes data from the test sites where test product 3 was applied.
This arm includes data from the test sites where test product 4 was applied.
This arm includes data from the test sites where reference product was applied.
Overall Number of Participants Analyzed 39 39 39 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
Day 2 (15-30 minutes) No effect
39
 100.0%
39
 100.0%
39
 100.0%
39
 100.0%
39
 100.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade A/Score 0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade B/Score 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade C/Score 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade F/Score 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade G/Score 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade H/Score 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 3 (24 hours) No effect
39
 100.0%
39
 100.0%
39
 100.0%
39
 100.0%
39
 100.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade A/Score 0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade B/Score 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade C/Score 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade F/Score 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade G/Score 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade H/Score 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 4 (48 hours) No effect
39
 100.0%
39
 100.0%
39
 100.0%
39
 100.0%
39
 100.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade A/Score 0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade B/Score 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade C/Score 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade F/Score 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade G/Score 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade H/Score 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame Approximately 4 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Product 1 Test Product 2 Test Product 3 Test Product 4 Reference Product Overall Participants
Hide Arm/Group Description This arm includes data from the test sites where test product 1 was applied. This arm includes data from the test sites where test product 2 was applied. This arm includes data from the test sites where test product 3 was applied. This arm includes data from the test sites where test product 4 was applied. This arm includes data from the test sites where reference product was applied. All participants randomized to the study. Test and control products were applied to a paper disc (or cell) contained within an adhesive patch. The number of cells available on the patch test tape is 6 (but only 5 cells were used, 4 test and 1 reference products). The patch was then applied onto the dorsum (scapula region) of each participant for a period of 24 ± 2 hours, the sequence of the product application to the cells was as per the randomization schedule
All-Cause Mortality
Test Product 1 Test Product 2 Test Product 3 Test Product 4 Reference Product Overall Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Test Product 1 Test Product 2 Test Product 3 Test Product 4 Reference Product Overall Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Test Product 1 Test Product 2 Test Product 3 Test Product 4 Reference Product Overall Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
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: NCT03233009     History of Changes
Other Study ID Numbers: 207235
First Submitted: July 7, 2017
First Posted: July 28, 2017
Results First Submitted: April 20, 2018
Results First Posted: September 7, 2018
Last Update Posted: January 16, 2019