Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

Conditions
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Aging

Intervention / Treatment
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* Drug: ER4017 (hydroxypropyltetrahydropyrantriol)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br> | Drug: ER4017 (hydroxypropyltetrahydropyrantriol)<br>* Cream, 10%, each day during 3 months<br>* Other names: ER4017;Drug: placebo<br> <br> |
| Experimental: hydroxypropyltetrahydropyrantriol<br> | Drug: ER4017 (hydroxypropyltetrahydropyrantriol)<br>* Cream, 10%, each day during 3 months<br>* Other names: ER4017;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aging, barrier function, transcriptomic