Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products

Dr. August Wolff

Status: Completed

Conditions: Aged Skin

Treatments: Other: C - pH 4 Cosmetic Product WO 3741; Other: D - pH 5.8 Cosmetic Product WO 4081-1

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03629405

PH4G-04/2016

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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20 participants in 4 patient groups

A - Negative control (untreated) for product C

No Intervention group

Description:

On the forearms four test areas were located, which were labeled from A-D. Test area A contralateral to product C

B - Negative control (untreated) for product D

No Intervention group

Description:

On the forearms four test areas were located, which were labeled from A-D. Test area B contralateral to product D

C - Cosmetic Product WO 3741 with pH 4

Experimental group

Description:

On the forearms four test areas were located, which were labeled from A-D. Test area C on the same arm like product D.

Treatment:

Other: C - pH 4 Cosmetic Product WO 3741

D - Cosmetic Product WO 4081-1 with pH 5.8

Experimental group

Description:

On the forearms four test areas were located, which were labeled from A-D.

Treatment:

Other: D - pH 5.8 Cosmetic Product WO 4081-1