Study on Anti-inflammatory Effects of Topical R115866 Gel
Overview
The purpose of this exploratory trial is to assess the anti-inflammatory effect(s) of topical R115866 in a model of UVB-induced inflammation and in a model of cutaneous irritation.
Full Title of Study: “Placebo-Controlled, Investigator Blinded, Explorative Trial to Evaluate the Anti-inflammatory Effect of Multiple Topical Applications of R115866 Gel (0.35%) in Two Models of Cutaneous Inflammation in Healthy Male Subjects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Investigator)
- Study Primary Completion Date: December 2006
Interventions
- Drug: Talarozole
- Topical Application (20 mg)
- Drug: Differin™, 0.1% adapalene gel
- Topical Application (20 mg)
Arms, Groups and Cohorts
- No Intervention: A
- No Treatment
- Active Comparator: B
- R115866 (0.35% gel)
- Active Comparator: C
- R115866 Vehicle gel
- Active Comparator: D
- Differin™, 0.1% adapalene gel
Clinical Trial Outcome Measures
Primary Measures
- Primary efficacy endpoint was the mean value of TEWL (Trans-epidermal water loss)
- Time Frame: Day 1 through Day 9 of treatment
Secondary Measures
- Erythema
- Time Frame: Day 1 through Day 8 of treatment and Day 15 post-treatment
Participating in This Clinical Trial
Inclusion Criteria
- Body Mass Index should be between 18 and 28 kg/m2 – Subjects are healthy as determined by medical history, physical examination and clinical laboratory tests carried out at screening – Subjects with a phototype III or IV (according to Fitzpatrick classification) Exclusion Criteria:
- Subjects with history of or active alcohol or substance abuse problems. – Known hypersensitivity to azoles, adapalene, retinoids or any other ingredient of the gels – Subjects who have a laboratory value which, in the opinion of the investigator, is clinically-relevant out of the normal range – Subjects with clinically relevant abnormal ECG-intervals or morphology of the ECG, QTc interval >450 ms – Use of vitamin A (>1000 µg/day) or the use of concomitant medication, except paracetamol; All other medication must have been stopped at least 14 days before the first administration of gel) – Subjects who have received an investigational product which is not a biological within the month preceding the screening visit; If the investigational product is a biological, a 3-month wash-out period is required. – Use of ultraviolet light (including artificial UVA and UVB as well as excessive natural sun exposure) unless stopped at Visit 1 – Subjects judged by the investigator to have a high probability of lack of compliance with the provisions of the protocol – Subjects having any medical condition which, in the opinion of the investigator at the site, is a contraindication to enrollment
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Stiefel, a GSK Company
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Prof. Dr. G. Piérard, MD, PhD, Principal Investigator, Department of Dermatopathology Centre Hospitalier Universitaire du Sart-Tilman
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