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Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

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ClinicalTrials.gov Identifier: NCT00818545
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : January 7, 2009
Sponsor:
Information provided by:
L'Oreal

Tracking Information
First Submitted Date  ICMJE January 6, 2009
First Posted Date  ICMJE January 7, 2009
Last Update Posted Date January 7, 2009
Study Start Date  ICMJE November 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2009)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcriptomic Study of ER 4017 Topical Application in Elderly Subject
Official Title  ICMJE Transcriptomic Study of ER 4017 Topical Application in Elderly Subject
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Aging
Intervention  ICMJE
  • Drug: ER4017 (hydroxypropyltetrahydropyrantriol)
    Cream, 10%, each day during 3 months
    Other Name: ER4017
  • Drug: placebo
Study Arms  ICMJE
  • Placebo Comparator: 2
    Interventions:
    • Drug: ER4017 (hydroxypropyltetrahydropyrantriol)
    • Drug: placebo
  • Experimental: hydroxypropyltetrahydropyrantriol
    Intervention: Drug: ER4017 (hydroxypropyltetrahydropyrantriol)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2009)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 60 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00818545
Other Study ID Numbers  ICMJE CRB-ER4017-07-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Tancrede and Pr L. Dubertret, Hôpital Saint-Louis, Centre de Recherche Bioclinique (CRB)
Study Sponsor  ICMJE L'Oreal
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Louis Dubertret, Prof centre de recherche bioclinique -Hopital st louis
PRS Account L'Oreal
Verification Date January 2009

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