Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products

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

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.

Study Overview

• Status: Completed
• Conditions: Aged Skin
• Intervention / Treatment: Other: C - pH 4 Cosmetic Product WO 3741; Other: D - pH 5.8 Cosmetic Product WO 4081-1

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schenefeld, Germany
    • proDERM Institute for Applied Dermatological Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: A - Negative control (untreated) for product C; 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; 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; 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; Application of the product on the pre-defined skin area on the forearms twice daily for four weeks
Experimental: D - Cosmetic Product WO 4081-1 with pH 5.8; On the forearms four test areas were located, which were labeled from A-D.	Other: D - pH 5.8 Cosmetic Product WO 4081-1; Application of the product on the pre-defined skin area on the forearms twice daily for four weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Collaborators: proDERM Institut für Angewandte Dermatologische Forschung GmbH; Microscopy Services Dähnhardt GmbH
• Investigators: Study Director: Prof. Klaus-Peter Wilhelm, MD, proDERM Institute for Applied Dermatological Research, Germany

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2016
• Primary Completion (Actual): September 9, 2016
• Study Completion (Actual): September 9, 2016

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: pH of the skin; SDS; Lipbarvis; TEWL; Skin hydration
• Other Study ID Numbers: PH4G-04/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No