Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this clinical study is to assess the relative mildness of a cosmetic facial cleanser in comparison to water through repeated application to the volar forearm using the FCAT wash procedure.
This is a test site randomized, examiner blinded, positive and negative-controlled, single-center; Forearm Controlled Application Technique clinical study in healthy participants to assess the mildness potential of a cosmetic facial cleansing product.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Other | 0.09 milliliters (ml) of the cleanser (test product) will be applied on the allocated site on forearm topically. |
|
| Positive Control | Other | Soap bar (positive control) will be applied on the allocated site on forearm by topical dermal administration of towel moistened with sterile water that had been rubbed onto the 100 g bar of soap for 6 seconds to generate a lather. |
|
| Negative Control | Other | 0.09 ml of sterile water (Reference Product) will be applied on the allocated site on forearm topically. |
|
| No Treatment | Other | An area of the forearm that remained unwashed and was included in the study as a reference for the treated areas. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Product | Other | Micellar cleanser (0.09 ml) |
| |
| Positive Control |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Visual Assessment of Dryness at Day 5 | 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. | At Baseline and Day 5 (3 hours post last wash procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Visual Assessment of Redness at Day 5 | 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. | At Baseline and Day 5 (3 hours post last wash procedure) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Campinas | São Paulo | 13084-791 | Brazil | ||
| GSK Investigational Site |
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).
Participants were recruited from one center in Brazil.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Overall Participants | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline parameters were reported for safety population. The safety population (N=48) included all participants who had received at least one wash procedure.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Visual Assessment of Dryness at Day 5 | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline and Day 5 (3 hours post last wash procedure) |
Approximately 5 days
All treatment emergent adverse events (AEs) were reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test | 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.. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FOOD POISONING | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2017 | Apr 16, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2017 | Apr 16, 2018 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Bar Soap (rubbed for 6 seconds to generate a lather) |
|
| Reference Product | Other | Sterile Water (0.09 ml) |
|
| No Treatment | Other | Unwashed area of the forearm |
|
| Change From Baseline in Visual Assessment of Dryness at Day 2, 3, and 4 | 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. | At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure) |
| Change From Baseline in Visual Assessment of Redness at Day 2, 3, and 4 | 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. | At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure) |
| Change From Baseline in Transepidermal Water Loss (TEWL) at Day 5 | 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. | At Baseline and Day 5 (3 hours post last wash procedure) |
| Change From Baseline in Skin Moisturisation at Day 5 | 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. | At Baseline and Day 5 (3 hours post last wash procedure) |
| Campinas |
| São Paulo |
| 13084- |
| Brazil |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Test | 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. |
| OG001 | Positive Control | Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study. |
| OG002 | Negative Control | 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. |
| OG003 | No Treatment | Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study. |
|
|
|
| Secondary | Change From Baseline in Visual Assessment of Redness at Day 5 | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline and Day 5 (3 hours post last wash procedure) |
|
|
|
| Secondary | Change From Baseline in Visual Assessment of Dryness at Day 2, 3, and 4 | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure) |
|
|
|
| Secondary | Change From Baseline in Visual Assessment of Redness at Day 2, 3, and 4 | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure) |
|
|
|
| Secondary | Change From Baseline in Transepidermal Water Loss (TEWL) at Day 5 | 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. | 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. | Posted | Mean | Standard Deviation | g/m^2/hr | At Baseline and Day 5 (3 hours post last wash procedure) |
|
|
|
| Secondary | Change From Baseline in Skin Moisturisation at Day 5 | 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. | 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. | Posted | Mean | Standard Deviation | i.u. | At Baseline and Day 5 (3 hours post last wash procedure) |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 4 |
| 48 |
| EG001 | Positive Control | Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study. | 0 | 48 | 0 | 48 | 4 | 48 |
| EG002 | Negative Control | 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. | 0 | 48 | 0 | 48 | 4 | 48 |
| EG003 | No Treatment | Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study. | 0 | 48 | 0 | 48 | 2 | 48 |
| EG004 | Overall Participants | Included all participants who applied any of the study products. | 0 | 48 | 0 | 48 | 6 | 48 |
| TOOTHACHE | Gastrointestinal disorders | Systematic Assessment |
|
| APPLICATION SITE PRURITUS | General disorders | Systematic Assessment |
|
| APPLICATION SITE PAIN | General disorders | Systematic Assessment |
|
| THERMAL BURN | Injury, poisoning and procedural complications | Systematic Assessment |
|
| ARTHROPOD BITE | Injury, poisoning and procedural complications | Systematic Assessment |
|
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.
|
| Day 3 |
|
|
| Day 4 |
|
|
|
| Day 3 |
|
|
| Day 4 |
|
|