Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-03-31

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.

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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.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2

Group Type PLACEBO_COMPARATOR

ER4017 (hydroxypropyltetrahydropyrantriol)

Intervention Type DRUG

Cream, 10%, each day during 3 months

placebo

Intervention Type DRUG

hydroxypropyltetrahydropyrantriol

Group Type EXPERIMENTAL

ER4017 (hydroxypropyltetrahydropyrantriol)

Intervention Type DRUG

Cream, 10%, each day during 3 months

Interventions

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ER4017 (hydroxypropyltetrahydropyrantriol)

Cream, 10%, each day during 3 months

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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ER4017

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).