Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products
NCT ID: NCT03629405
Last Updated: 2018-08-14
Study Results
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-08-11
2016-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
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
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
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.
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 - Cosmetic Product WO 4081-1 with pH 5.8
On the forearms four test areas were located, which were labeled from A-D.
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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
75 Years
ALL
Yes
Sponsors
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proDERM Institut für Angewandte Dermatologische Forschung GmbH
UNKNOWN
Microscopy Services Dähnhardt GmbH
UNKNOWN
Dr. August Wolff GmbH & Co. KG Arzneimittel
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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PH4G-04/2016
Identifier Type: -
Identifier Source: org_study_id
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