Aging Clinical Trial - Transcriptomic Study of ER 4017 Topical Application

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Aging

Clinical Trial Details

NCT number	NCT00818545
Study type	Interventional
Source	L'Oreal
Contact
Status	Completed
Phase	N/A
Start date	November 2007
Completion date	March 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05433233` - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension	N/A
Recruiting	`NCT06032065` - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)	Phase 3
Completed	`NCT05293730` - Trial of the Impact of the Electronic Frailty Integrated With Social Needs	N/A
Recruiting	`NCT03932162` - Gene Expression Changes In Young and Geriatric Skin	Early Phase 1
Completed	`NCT04064528` - Effects of Age on Amino Acid Delivery to Tendon	N/A
Completed	`NCT03366129` - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed	`NCT06029920` - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment	N/A
Recruiting	`NCT05566938` - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly	N/A
Recruiting	`NCT05543980` - Leg Heat Therapy in Elderly Individuals	Phase 2
Completed	`NCT04894929` - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement	N/A
Not yet recruiting	`NCT06071130` - Emotion, Aging, and Decision Making	N/A
Enrolling by invitation	`NCT04641663` - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST)	N/A
Completed	`NCT04088006` - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity	N/A
Completed	`NCT03695081` - Patient Pathway Pharmacist - Optimal Drug-related Care	N/A
Recruiting	`NCT05424263` - Acetate and Age-associated Arterial Dysfunction	Phase 2
Completed	`NCT05601713` - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling	N/A
Completed	`NCT04551339` - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19	N/A
Recruiting	`NCT04997577` - Speech Perception and High Cognitive Demand	N/A
Completed	`NCT05922475` - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training	N/A
Completed	`NCT04015479` - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms