Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03629405

Enrollment

Registered

2018-08-14

Start date

2016-08-11

Completion date

2016-09-09

Last updated

2018-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aged Skin

Keywords

pH of the skin, SDS, Lipbarvis, TEWL, Skin hydration

Brief summary

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.

Interventions

OTHERC - pH 4 Cosmetic Product WO 3741

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

OTHERD - 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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Skin pH	baseline, Day 29, Day 30	Change from baseline at Day 29 and Day 30 of Skin pH Units assessed by pH-meter

Secondary

Measure	Time frame	Description
Transepidermal Water Loss	baseline, Day 29, Day 30	Change from baseline at Day 29 and Day 30 of Transepidermal Water Loss (g/m2/h) assessed by Tewameter
Skin Hydration	baseline, Day 29, Day 30	Change from baseline at Day 29 and Day 30 of Skin Hydration Arbitrary Units assessed by Corneometer
Intercellular lipid lamellae lenght (nm ICLL/1000 nm2 ICS)	baseline, Day 29, Day 30	Change from baseline at Day 29 and Day 30 of stratum corneum assessed by transmission electron microscopy
Lipid Analysis ((concentration of : Cholesterol (µg/slide), FFA (µg/slide), Ceramide EOS (µg/slide), Ceramide NP (µg/slide), Ceramide NH (µg/slide))	baseline, Day 29, Day 30	Change from baseline at Day 29 and Day 30 of corneocyte layer area assessed from the TEM data

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026