Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

NCT00818545 | Completed DMC

• 1 other identifier: CRB-ER4017-07-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The stratum corneum (SC) is the superficial layer of the epidermis situated at the interface between the body and its outside environment. Its strategic position confers it a crucial role of protection against aggressions. After disruption, the kinetic of cutaneous barrier is slower in elderly comparatively to young subjects. The purpose of this study is to investigate, by characterizing molecular events, the effectiveness of ER4017 (Hydroxypropyltetrahydropyrantriol) to restore kinetic barrier function after acute disruption of stratum corneum in ederly subjects. 10 male volunteers aged from 60 to 75 years are randomized to receive topical application of ER4017 versus placebo on skin inner forearms twice a day during 3 months. After sequential selloptape strips, epidermal samples of treated and control skin are removed under local anesthesia, using a dermatome. Differential gene expression analysis is performed using micro array techniques and quantitative RT-PCR. treatment, randomized on the location, double blind, placebo control, internal control subject, prospective study.

Conditions

Aging

Keywords

aging; barrier function; transcriptomic

Outcome Measures

Primary Outcomes (1)

• Investigate the effectiveness of an anti aging topical treatment by characterizing molecular modifications linked to barrier function recovery following a disruption of stratum corneum.

  day 0(visit selection), day 1 (inclusion visit), day 2 to day 84 (treatment period), day 85 (end of the treatment), day 92 and day 99 (follow up period)

Study Arms (2)

2

PLACEBO COMPARATOR

Drug: ER4017 (hydroxypropyltetrahydropyrantriol); Drug: placebo

hydroxypropyltetrahydropyrantriol

EXPERIMENTAL

Drug: ER4017 (hydroxypropyltetrahydropyrantriol)

Interventions

ER4017 (hydroxypropyltetrahydropyrantriol) DRUG

Cream, 10%, each day during 3 months

Also known as: ER4017

2; hydroxypropyltetrahydropyrantriol

placebo DRUG

2

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phototype I to III
• Healthy skin on studied skin areas
• Subject having freely given his informed written consent.
• Cooperative subject, aware of the necessity to attend all the scheduled appointments during the study.
• Negative serology for HIV, hepatitis B and hepatitis C
• No past or present history of allergy linked either to one of the ingredients of the study cosmetic cream tested or to xylocaïne (anesthesia).

You may not qualify if:

• Cutaneous disease or previous malignant cutaneous lesion on the tested zones.
• Any treatment able to act on blood coagulation and homeostasis.

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

Centre de recherche bioclinique -Hopital st louis

Paris, 75010, France

Location

Study Officials

• Louis Dubertret, Prof

  centre de recherche bioclinique -Hopital st louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 7, 2009
• Study Start: November 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: January 7, 2009

Record last verified: 2009-01

Locations

FR (1)