Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products

D

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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