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

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)

Population: 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.

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)

Population: 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.

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)

Population: 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.

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)

Population: 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.

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)

Population: 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.

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)

Population: 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.