Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products

NCT ID: NCT03629405

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-11

Study Completion Date

2016-09-09

Brief Summary

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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

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Conditions

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Aged Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

C - pH 4 Cosmetic Product WO 3741

Intervention Type OTHER

Application of the product on the pre-defined skin area on the forearms twice daily for four weeks

D - Cosmetic Product WO 4081-1 with pH 5.8

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

Group Type EXPERIMENTAL

D - pH 5.8 Cosmetic Product WO 4081-1

Intervention Type OTHER

Application of the product on the pre-defined skin area on the forearms twice daily for four weeks

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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proDERM Institut für Angewandte Dermatologische Forschung GmbH

UNKNOWN

Sponsor Role collaborator

Microscopy Services Dähnhardt GmbH

UNKNOWN

Sponsor Role collaborator

Dr. August Wolff GmbH & Co. KG Arzneimittel

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Klaus-Peter Wilhelm, MD

Role: STUDY_DIRECTOR

proDERM Institute for Applied Dermatological Research, Germany

Locations

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proDERM Institute for Applied Dermatological Research

Schenefeld, , Germany

Site Status

Countries

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Germany

Other Identifiers

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PH4G-04/2016

Identifier Type: -

Identifier Source: org_study_id

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