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

January 6, 2009
January 6, 2009
November 2007
March 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Transcriptomic Study of ER 4017 Topical Application in Elderly Subject
Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Aging
  • Drug: ER4017 (hydroxypropyltetrahydropyrantriol)
    Cream, 10%, each day during 3 months
    Other Name: ER4017
  • Drug: placebo
  • Placebo Comparator: 2
    Interventions:
    • Drug: ER4017 (hydroxypropyltetrahydropyrantriol)
    • Drug: placebo
  • Experimental: hydroxypropyltetrahydropyrantriol
    Intervention: Drug: ER4017 (hydroxypropyltetrahydropyrantriol)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Male
60 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00818545
CRB-ER4017-07-01
Yes
Dr Tancrede and Pr L. Dubertret, Hôpital Saint-Louis, Centre de Recherche Bioclinique (CRB)
L'Oreal
Not Provided
Principal Investigator: Louis Dubertret, Prof centre de recherche bioclinique -Hopital st louis
L'Oreal
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP