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Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

This study has been completed.
Sponsor:
Information provided by:
L'Oreal
ClinicalTrials.gov Identifier:
NCT00818545
First received: January 6, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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 Intervention
Aging
 Drug: ER4017 (hydroxypropyltetrahydropyrantriol)
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by L'Oreal:

Primary Outcome Measures:
  • Investigate the effectiveness of an anti aging topical treatment by characterizing molecular modifications linked to barrier function recovery following a disruption of stratum corneum. [ Time Frame: 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) ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: November 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2 Drug: ER4017 (hydroxypropyltetrahydropyrantriol)
Cream, 10%, each day during 3 months
Other Name: ER4017
Drug: placebo
Experimental: hydroxypropyltetrahydropyrantriol Drug: ER4017 (hydroxypropyltetrahydropyrantriol)
Cream, 10%, each day during 3 months
Other Name: ER4017

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818545

Locations
France
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
  More Information

No publications provided

Responsible Party: Dr Tancrede and Pr L. Dubertret, Hôpital Saint-Louis, Centre de Recherche Bioclinique (CRB)
ClinicalTrials.gov Identifier: NCT00818545     History of Changes
Other Study ID Numbers: CRB-ER4017-07-01
Study First Received: January 6, 2009
Last Updated: January 6, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by L'Oreal:
aging
barrier function
transcriptomic

ClinicalTrials.gov processed this record on June 18, 2013