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Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

Sponsor
L'Oreal (Industry)
Overall Status
Completed
CT.gov ID
NCT00818545
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
4
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ER4017 (hydroxypropyltetrahydropyrantriol)
  • Drug: placebo
 N/A

Detailed Description

Structural modifications of the superficial dermis during the aging process associated to alterations in the GAG- and PG profile appear to impact the quality of the dermal epidermal junction (DEJ). Previous biological and clinical evaluations of ER4017, a C-glycoside biomimetic of xylose, showed its capacity to stimulate GAG- and PG synthesis and to improve morphogenesis of the whole DEJ.

The aim of the study is to investigate the gene expression in human epidermis treated with ER4017 following sequential sellotapes strips after a 3 months ER4017 topical application. For this purpose, the modulation of gene expression is determined using a cDNA microarray technology. Stratum corneum disruption is performed following 3 months topical application on skin inner forearms. All the experiments are performed in 10 elderly healthy men. Volunteers are clinically and biophysically evaluated at baseline and then at monthly intervals or at 3 months respectively.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Transcriptomic Study of ER 4017 Topical Application in Elderly Subject
Study Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 2

Drug: ER4017 (hydroxypropyltetrahydropyrantriol)
Cream, 10%, each day during 3 months
Other Names:
  • ER4017

    • Drug: placebo
    Experimental: hydroxypropyltetrahydropyrantriol

    Drug: ER4017 (hydroxypropyltetrahydropyrantriol)
    Cream, 10%, each day during 3 months
    Other Names:
  • ER4017

    		•

    Outcome Measures

    Primary Outcome Measures

    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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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).

    Exclusion Criteria:

    • Cutaneous disease or previous malignant cutaneous lesion on the tested zones.

    • Any treatment able to act on blood coagulation and homeostasis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre de recherche bioclinique -Hopital st louis Paris France 75010

    Sponsors and Collaborators

    • L'Oreal

    Investigators

    • Principal Investigator: Louis Dubertret, Prof, centre de recherche bioclinique -Hopital st louis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00818545
    Other Study ID Numbers:
    • CRB-ER4017-07-01
    First Posted:
    Jan 7, 2009
    Last Update Posted:
    Jan 7, 2009
    Last Verified:
    Jan 1, 2009
    Keywords provided by , ,
    aging
    barrier function
    transcriptomic

    Study Results

    No Results Posted as of Jan 7, 2009