Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products

Not Applicable

Completed

• Conditions: Aged Skin
• Interventions: Other: C - pH 4 Cosmetic Product WO 3741; Other: D - pH 5.8 Cosmetic Product WO 4081-1

• Registration Number: NCT03629405
• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-11
• Primary Completion: 2016-09-09
• Study Completion: 2016-09-09
• Status Verified: 2018-08
• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-10
• Last Update Submitted: 2018-08-10
• Study First Posted: 2018-08-14
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C - Cosmetic Product WO 3741 with pH 4	C - pH 4 Cosmetic Product WO 3741	On the forearms four test areas were located, which were labeled from A-D. Test area C on the same arm like product D.
D - Cosmetic Product WO 4081-1 with pH 5.8	D - pH 5.8 Cosmetic Product WO 4081-1	On the forearms four test areas were located, which were labeled from A-D.

Primary Outcome Measures

Name	Time	Method
Skin pH	baseline, Day 29, Day 30	Change from baseline at Day 29 and Day 30 of Skin pH Units assessed by pH-meter

Secondary Outcome Measures

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

Trial Locations

Locations (1)

proDERM Institute for Applied Dermatological Research; 🇩🇪 Schenefeld, Germany