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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical Study to Assess the Mildness of a Cosmetic Cleanser in Healthy Subjects Using the Forearm-Controlled Application Technique (FCAT)

Conditions
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Skin Care

Intervention / Treatment
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* Other: Test Product
* Other: Positive Control
* Other: Reference Product
* Other: No Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. Aged between 18 and 65 years inclusive. Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination. Intact skin at the proposed application site; volar forearm. Clinical assessment for eligibility by a dermatologist to ensure participant is free of clinically relevant dermatological conditions. Fitzpatrick phototype I to IV. Trained examiner scores of zero for dryness and redness for each volar forearm at Screening visit (Visit 1) and each allocated test site on each forearm at Baseline visit. Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits. Exclusion Criteria: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. Women who are breast-feeding Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction. Presence of open sores, pimples, or cysts at the application site. Active dermatosis (local or disseminated) that might interfere with the results of the study. Considered immune compromised. History of diseases aggravated or triggered by ultraviolet radiation. History of atopic dermatitis. Participants with dermatographism. Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the participant at undue risk. Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids upto 2 weeks before screening visit. Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit. Intention of being vaccinated during the study period or has been vaccinated within 3 weeks of the screening visit. Currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation. Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics or medication. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit. Previous participation in this study. Recent history (within the last 5 years) of alcohol or other substance abuse. Intense sunlight exposure or sun tanning sessions, including use of self-tanning products on the test areas up to 14 days before the Screening evaluation. Intention of bathing (in the sea or pool), sauna, water sports, or activities that lead to intense sweating. Any Participant who, in the judgment of the Investigator and Dermatologist, should not participate in the study. Any skin marks on the test site that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles). Prisoner or involuntary incarcerated participant Participant from an indigenous tribe. An employee of the sponsor or the study site or members of their immediate family.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Test product<br>0.09 milliliters (ml) of the cleanser (test product) will be applied on the allocated site on forearm topically. | Other: Test Product<br>* Micellar cleanser (0.09 ml)<br>|
| Other: Positive Control<br>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. | Other: Positive Control<br>* Bar Soap (rubbed for 6 seconds to generate a lather)<br>|
| Other: Negative Control<br>0.09 ml of sterile water (Reference Product) will be applied on the allocated site on forearm topically. | Other: Reference Product<br>* Sterile Water (0.09 ml)<br>|
| Other: No Treatment<br>An area of the forearm that remained unwashed and was included in the study as a reference for the treated areas. | Other: No Treatment<br>* Unwashed area of the forearm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |