Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products

Study Overview
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Brief Summary
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The aim of the study was to assess the long-term efficacy and barrier protection properties of two cosmetic products on the volar forearms of 20 elderly subjects after four weeks of treatment compared to two untreated test areas.

Official Title
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Assessment of the Long-Term Efficacy and Barrier Protection of Two Skin Care Products

Conditions
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Aged Skin

Intervention / Treatment
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* Other: C - pH 4 Cosmetic Product WO 3741
* Other: D - pH 5.8 Cosmetic Product WO 4081-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written Informed Consent to participate in the study Willingness to actively participate in the study and to come to the scheduled visits Female and male (at least 30% male subjects) From 50 to 75 years of age, equally distributed Exclusion Criteria: Female subjects: Pregnancy or lactation Drug addicts, alcoholics AIDS or infectious hepatitis if known to the subjects Conditions which exclude a participation or might influence the test reaction/ evaluation Participation or being in the waiting period after participation in similar cosmetic and/or pharmaceutical studies Active skin disease at the test area One of the following serious illnesses that might require regular systemic medication: insulin-dependent diabetes Moles, tattoos, scars, irritated skin, hairs, etc. at the test area that could influence the Investigation

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A - Negative control (untreated) for product C<br>On the forearms four test areas were located, which were labeled from A-D. Test area A contralateral to product C | |
| No Intervention: B - Negative control (untreated) for product D<br>On the forearms four test areas were located, which were labeled from A-D. Test area B contralateral to product D | |
| Experimental: C - Cosmetic Product WO 3741 with pH 4<br>On the forearms four test areas were located, which were labeled from A-D. Test area C on the same arm like product D. | Other: C - pH 4 Cosmetic Product WO 3741<br>* Application of the product on the pre-defined skin area on the forearms twice daily for four weeks<br>|
| Experimental: D - Cosmetic Product WO 4081-1 with pH 5.8<br>On the forearms four test areas were located, which were labeled from A-D. | Other: D - pH 5.8 Cosmetic Product WO 4081-1<br>* Application of the product on the pre-defined skin area on the forearms twice daily for four weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin pH | Change from baseline at Day 29 and Day 30 of Skin pH Units assessed by pH-meter | baseline, Day 29, Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transepidermal Water Loss | Change from baseline at Day 29 and Day 30 of Transepidermal Water Loss (g/m2/h) assessed by Tewameter | baseline, Day 29, Day 30 | 
| Skin Hydration | Change from baseline at Day 29 and Day 30 of Skin Hydration Arbitrary Units assessed by Corneometer | baseline, Day 29, Day 30 | 
| Intercellular lipid lamellae lenght (nm ICLL/1000 nm2 ICS) | Change from baseline at Day 29 and Day 30 of stratum corneum assessed by transmission electron microscopy | baseline, Day 29, Day 30 | 
| Lipid Analysis ((concentration of : Cholesterol (µg/slide), FFA (µg/slide), Ceramide EOS (µg/slide), Ceramide NP (µg/slide), Ceramide NH (µg/slide)) | Change from baseline at Day 29 and Day 30 of corneocyte layer area assessed from the TEM data | baseline, Day 29, Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pH of the skin, SDS, Lipbarvis, TEWL, Skin hydration