Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products

Aged Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629405
• Other study ID #: PH4G-04/2016
• Status: Completed
• Phase: N/A
• Start date: August 11, 2016
• Est. completion date: September 9, 2016

Study information

• Verified date: August 2018
• Source: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 9, 2016
• Est. primary completion date: September 9, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aged Skin

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	proDERM Institute for Applied Dermatological Research	Schenefeld

Sponsors (3)

Lead Sponsor	Collaborator
Dr. August Wolff GmbH & Co. KG Arzneimittel	Microscopy Services Dähnhardt GmbH, proDERM Institut für Angewandte Dermatologische Forschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Skin Hydration	Change from baseline at Day 29 and Day 30 of Skin Hydration Arbitrary Units assessed by Corneometer	baseline, Day 29, Day 30
Secondary	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
Secondary	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