NCT03629405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

29 days

First QC Date

August 10, 2018

Last Update Submit

August 10, 2018

Conditions

Aged Skin

Keywords

pH of the skinSDSLipbarvisTEWLSkin hydration

Outcome Measures

Primary Outcomes (1)

  • Skin pH

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

    baseline, Day 29, Day 30

Secondary Outcomes (4)

  • Transepidermal Water Loss

    baseline, Day 29, Day 30

  • Skin Hydration

    baseline, Day 29, Day 30

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

    baseline, Day 29, Day 30

  • 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

Study Arms (4)

A - Negative control (untreated) for product C

NO INTERVENTION

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

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

On the forearms four test areas were located, which were labeled from A-D. Test area C on the same arm like product D.

Other: C - pH 4 Cosmetic Product WO 3741

D - Cosmetic Product WO 4081-1 with pH 5.8

EXPERIMENTAL

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

Other: D - pH 5.8 Cosmetic Product WO 4081-1

Interventions

C - pH 4 Cosmetic Product WO 3741OTHER

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

C - Cosmetic Product WO 3741 with pH 4
D - pH 5.8 Cosmetic Product WO 4081-1OTHER

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

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

proDERM Institute for Applied Dermatological Research

Schenefeld, Germany

Location

Study Officials

  • Prof. Klaus-Peter Wilhelm, MD

    proDERM Institute for Applied Dermatological Research, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 14, 2018

Study Start

August 11, 2016

Primary Completion

September 9, 2016

Study Completion

September 9, 2016

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)