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Completed

NCT Number: NCT03629405

Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products

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.

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Key information

Conditions

Aged Skin

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

proDERM Institute for Applied Dermatological Research

Schenefeld, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C - pH 4 Cosmetic Product WO 3741

Other

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

Other

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

Primary outcomes

  1. Skin pH

    Time frame: baseline, Day 29, Day 30

    Change from baseline at Day 29 and Day 30 of Skin pH Units assessed by pH-meter

Secondary outcomes

  1. Transepidermal Water Loss

    Time frame: baseline, Day 29, Day 30

    Change from baseline at Day 29 and Day 30 of Transepidermal Water Loss (g/m2/h) assessed by Tewameter

  2. Skin Hydration

    Time frame: baseline, Day 29, Day 30

    Change from baseline at Day 29 and Day 30 of Skin Hydration Arbitrary Units assessed by Corneometer

  3. Intercellular lipid lamellae lenght (nm ICLL/1000 nm2 ICS)

    Time frame: baseline, Day 29, Day 30

    Change from baseline at Day 29 and Day 30 of stratum corneum assessed by transmission electron microscopy

  4. Lipid Analysis ((concentration of : Cholesterol (µg/slide), FFA (µg/slide), Ceramide EOS (µg/slide), Ceramide NP (µg/slide), Ceramide NH (µg/slide))

    Time frame: baseline, Day 29, Day 30

    Change from baseline at Day 29 and Day 30 of corneocyte layer area assessed from the TEM data

Sponsors and collaborators

Lead sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Industry

Collaborators

  • Microscopy Services Dähnhardt GmbH
  • proDERM Institut für Angewandte Dermatologische Forschung GmbH

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2018
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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