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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