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Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00818545
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : January 7, 2009
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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
Aging Drug: ER4017 (hydroxypropyltetrahydropyrantriol) Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Arm Intervention/treatment
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

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. [ 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00818545

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Centre de recherche bioclinique -Hopital st louis
Paris, France, 75010
Sponsors and Collaborators
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Principal Investigator: Louis Dubertret, Prof centre de recherche bioclinique -Hopital st louis

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Responsible Party: Dr Tancrede and Pr L. Dubertret, Hôpital Saint-Louis, Centre de Recherche Bioclinique (CRB) Identifier: NCT00818545     History of Changes
Other Study ID Numbers: CRB-ER4017-07-01
First Posted: January 7, 2009    Key Record Dates
Last Update Posted: January 7, 2009
Last Verified: January 2009
Keywords provided by L'Oreal:
barrier function