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To Assess the Mildness of a Cosmetic Cleanser in Healthy Participants Using the Forearm-Controlled Application Technique (FCAT)

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ClinicalTrials.gov Identifier: NCT03119688
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Skin Care
Interventions Other: Test Product
Other: Positive Control
Other: Reference Product
Other: No Treatment
Enrollment 50
Recruitment Details Participants were recruited from one center in Brazil.
Pre-assignment Details A total of 89 participants were screened, out of which 39 participants did not meet the study criteria. Remaining 50 participants were enrolled in the study, out of which 2 participants were not randomized to the study due to adverse events (AEs).
Arm/Group Title Overall Participants
Hide Arm/Group Description All participants enrolled in the study received all the study products and received at least 1 wash procedure. Each participant received 9 controlled wash applications over 5 days of test product (0.09 mL), positive control (soap bar) and negative control (0.09 mL) at each allocated test site. Therefore, each participant received a total of 27 applications of study products. Each wash procedure included a 10-second application of the test product, followed by a 90-second wait and a 15-second rinse-off with sterile water.
Period Title: Overall Study
Started 48
Completed 44
Not Completed 4
Reason Not Completed
Adverse Event             4
Arm/Group Title Overall Participants
Hide Arm/Group Description All participants enrolled in the study received all the study products and received at least 1 wash procedure. Each participant received 9 controlled wash applications over 5 days of test product (0.09 mL), positive control (soap bar) and negative control (0.09 mL) at each allocated test site. Therefore, each participant received a total of 27 applications of study products. Each wash procedure included a 10-second application of the test product, followed by a 90-second wait and a 15-second rinse-off with sterile water.
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
Baseline parameters were reported for safety population. The safety population (N=48) included all participants who had received at least one wash procedure.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
39.1  (13.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
47
  97.9%
Male
1
   2.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
American Indian or Alaska Native
1
   2.1%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
  16.7%
White
39
  81.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Visual Assessment of Dryness at Day 5
Hide Description Skin dryness was assessed by a trained examiner according to following the scoring scale: 0 (No dryness); 1 (Patches of slight powederiness and occasional patches of small scales may be seen, distribution generalized.); 2 (Generalised slight powederiness, early cracking or occasional small lifting scales may be present); 3 (Generalised moderate powederiness and/or heavy cracking and lifting scales; 4 (Generalised heavy powederiness and/or heavy cracking and lifting scales); 5 (Generalised high cracking and lifting scales, eczematous change may be present, powederiness may be present but not prominent, may see bleeding crack); 6 (Generalised severe cracking, eczematous change may be present, bleeding cracks may be present, scale large may be beginning to disappear). Lower scores reflect less dry skin.
Time Frame At Baseline and Day 5 (3 hours post last wash procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment. Number of participants analyzed for this endpoint were part of the ITT population, evaluated on Day 5.
Arm/Group Title Test Positive Control Negative Control No Treatment
Hide Arm/Group Description:
Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser) was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water) was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study.
Overall Number of Participants Analyzed 44 44 44 44
Mean (Standard Deviation)
Unit of Measure: Score on a scale
0.48  (0.284) 0.91  (0.291) 0.56  (0.290) 0.63  (0.307)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Negative Control
Comments The null hypothesis (non-inferiority setting) is that the population mean dryness for Test minus Baxter Sterile Water (negative control) is at least 0.25.
Type of Statistical Test Non-Inferiority
Comments The non-Inferiority margin is set at 0.25. The upper limit of the 90% CI is less than this and hence NI is met.
Statistical Test of Hypothesis P-Value 0.1769
Comments No adjustment for multiple comparisons was made.
Method ANOVA
Comments ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.077
Confidence Interval (2-Sided) 90%
-0.1707 to 0.0169
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Positive Control, Negative Control
Comments The null hypothesis is that the difference in population mean dryness is zero.
Type of Statistical Test Superiority
Comments This is a superiority test setting.
Statistical Test of Hypothesis P-Value <.0001
Comments No adjustment for multiple comparisons was made.
Method ANOVA
Comments ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.350
Confidence Interval (2-Sided) 90%
0.2565 to 0.4441
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Test, Positive Control
Comments The null hypothesis is that the difference in population mean dryness is zero.
Type of Statistical Test Superiority
Comments This is a superiority test setting.
Statistical Test of Hypothesis P-Value <.0001
Comments No adjustment for multiple comparisons was made.
Method ANOVA
Comments ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.427
Confidence Interval (2-Sided) 90%
0.3333 to 0.5211
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Negative Control, No Treatment
Comments The null hypothesis is that the difference in population mean dryness is zero.
Type of Statistical Test Superiority
Comments This is a superiority test setting.
Statistical Test of Hypothesis P-Value 0.2518
Comments No adjustment for multiple comparisons was made.
Method ANOVA
Comments ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.065
Confidence Interval (2-Sided) 90%
-0.0287 to 0.1592
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.
2.Secondary Outcome
Title Change From Baseline in Visual Assessment of Redness at Day 5
Hide Description Skin redness was assessed by a trained examiner according to following the scoring scale: 0 (No redness); 1(Barely detectable redness); 2(Slight redness); 3 (Moderate redness); 4 (Heavy or substantial redness); 5 (Extreme redness); 6 (Severe Redness). Lower scores reflect less skin redness.
Time Frame At Baseline and Day 5 (3 hours post last wash procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment. Number of participants analyzed for this endpoint were part of the ITT population, evaluated on Day 5.
Arm/Group Title Test Positive Control Negative Control No Treatment
Hide Arm/Group Description:
Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser)was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water ) was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study.
Overall Number of Participants Analyzed 44 44 44 44
Mean (Standard Deviation)
Unit of Measure: Score on a scale
0.01  (0.075) 0.00  (0.00) 0.00  (0.00) 0.00  (0.00)
3.Secondary Outcome
Title Change From Baseline in Visual Assessment of Dryness at Day 2, 3, and 4
Hide Description Skin dryness was assessed by a trained examiner according to following the scoring scale: 0 (No dryness); 1 (Patches of slight powederiness and occasional patches of small scales may be seen, distribution generalized.); 2 (Generalised slight powederiness, early cracking or occasional small lifting scales may be present); 3 (Generalised moderate powederiness and/or heavy cracking and lifting scales; 4 (Generalised heavy powederiness and/or heavy cracking and lifting scales); 5 (Generalised high cracking and lifting scales, eczematous change may be present, powederiness may be present but not prominent, may see bleeding crack); 6 (Generalised severe cracking, eczematous change may be present, bleeding cracks may be present, scale large may be beginning to disappear). Lower scores reflect less dry skin.
Time Frame At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment.
Arm/Group Title Test Positive Control Negative Control Reference (Unwashed Area)
Hide Arm/Group Description:
Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser)was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water) was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study.
Overall Number of Participants Analyzed 48 48 48 48
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 2 Number Analyzed 48 participants 48 participants 48 participants 48 participants
0.25  (0.253) 0.46  (0.307) 0.28  (0.251) 0.31  (0.265)
Day 3 Number Analyzed 45 participants 45 participants 45 participants 45 participants
0.37  (0.248) 0.66  (0.298) 0.38  (0.285) 0.42  (0.260)
Day 4 Number Analyzed 44 participants 44 participants 44 participants 44 participants
0.43  (0.255) 0.76  (0.314) 0.42  (0.240) 0.55  (0.302)
4.Secondary Outcome
Title Change From Baseline in Visual Assessment of Redness at Day 2, 3, and 4
Hide Description Skin redness was assessed by a trained examiner according to following the scoring scale: 0 (No redness); 1(Barely detectable redness); 2(Slight redness); 3 (Moderate redness); 4 (Heavy or substantial redness); 5 (Extreme redness); 6 (Severe Redness). Lower scores reflect less skin redness.
Time Frame At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment.
Arm/Group Title Test Positive Control Negative Control Reference (Unwashed Area)
Hide Arm/Group Description:
Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser) was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water ) was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study
Overall Number of Participants Analyzed 48 48 48 48
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 2 Number Analyzed 48 participants 48 participants 48 participants 48 participants
0.06  (0.167) 0.05  (0.154) 0.01  (0.072) 0.01  (0.072)
Day 3 Number Analyzed 45 participants 45 participants 45 participants 48 participants
0.00  (0.00) 0.00  (0.00) 0.00  (0.00) 0.00  (0.00)
Day 4 Number Analyzed 44 participants 44 participants 44 participants 48 participants
0.00  (0.00) 0.01  (0.075) 0.00  (0.00) 0.02  (0.151)
5.Secondary Outcome
Title Change From Baseline in Transepidermal Water Loss (TEWL) at Day 5
Hide Description TEWL was measured using Tewameter. TEWL measuring principle was based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 seconds (sec), to ensure that a stable value has been established. The first part of the measurement belonged to the equilibration phase. The values of the last 10 sec were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.
Time Frame At Baseline and Day 5 (3 hours post last wash procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment. Number of participants analyzed for this endpoint were part of the ITT population, evaluated on Day 5.
Arm/Group Title Test Product Positive Control Negative Control No Treatment
Hide Arm/Group Description:
Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser)was applied during the study..
Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water ) was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study.
Overall Number of Participants Analyzed 44 44 44 44
Mean (Standard Deviation)
Unit of Measure: g/m^2/hr
0.91  (2.118) 1.95  (2.025) 0.94  (1.714) 0.53  (1.682)
6.Secondary Outcome
Title Change From Baseline in Skin Moisturisation at Day 5
Hide Description Corneometry was used to measure moisture content of stratum corneum using corneometer. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the gold conductors of the probe an electrical field was built which allowed the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content, the stratum corneum moisturisation can be measured. The Corneometer probe was placed in contact with the skin of the paarticipant's test site for 1-2 seconds per measurement. The Corneometer measurements were taken and an average (mean) reading was calculated for each site and time point. Corneometer values lower than 30 instrumental units (i.u.) represents very dry skin, while values between 30 und 50 i.u are typically for dry skin on the forearm. An increase in Corneometer values, therefore, corresponds to a skin-moisturising effect.
Time Frame At Baseline and Day 5 (3 hours post last wash procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment. Number of participants analyzed for this endpoint were part of the ITT population, evaluated on Day 5.
Arm/Group Title Test Positive Control Negative Control No Treatment
Hide Arm/Group Description:
Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser)was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study.
Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water) was applied during the study
Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study.
Overall Number of Participants Analyzed 44 44 44 44
Mean (Standard Deviation)
Unit of Measure: i.u.
2.35  (5.341) -4.57  (5.368) 2.13  (4.803) 0.34  (3.729)
Time Frame Approximately 5 days
Adverse Event Reporting Description All treatment emergent adverse events (AEs) were reported.
 
Arm/Group Title Test Positive Control Negative Control No Treatment Overall Participants
Hide Arm/Group Description Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser) was applied during the study.. Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study. Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water) was applied during the study. Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study. Included all participants who applied any of the study products.
All-Cause Mortality
Test Positive Control Negative Control No Treatment Overall Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/48 (0.00%)   0/48 (0.00%)   0/48 (0.00%)   0/48 (0.00%) 
Hide Serious Adverse Events
Test Positive Control Negative Control No Treatment Overall Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/48 (0.00%)   0/48 (0.00%)   0/48 (0.00%)   0/48 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Test Positive Control Negative Control No Treatment Overall Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/48 (8.33%)   4/48 (8.33%)   4/48 (8.33%)   2/48 (4.17%)   6/48 (12.50%) 
Gastrointestinal disorders           
FOOD POISONING   1/48 (2.08%)  1/48 (2.08%)  1/48 (2.08%)  1/48 (2.08%)  1/48 (2.08%) 
TOOTHACHE   1/48 (2.08%)  1/48 (2.08%)  1/48 (2.08%)  1/48 (2.08%)  1/48 (2.08%) 
General disorders           
APPLICATION SITE PRURITUS   1/48 (2.08%)  0/48 (0.00%)  0/48 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
APPLICATION SITE PAIN   0/48 (0.00%)  1/48 (2.08%)  2/48 (4.17%)  0/48 (0.00%)  2/48 (4.17%) 
Injury, poisoning and procedural complications           
THERMAL BURN   1/48 (2.08%)  0/48 (0.00%)  0/48 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
ARTHROPOD BITE   0/48 (0.00%)  1/48 (2.08%)  0/48 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03119688    
Other Study ID Numbers: 207619
First Submitted: April 5, 2017
First Posted: April 18, 2017
Results First Submitted: April 20, 2018
Results First Posted: May 2, 2019
Last Update Posted: May 2, 2019