Study on Anti-inflammatory Effects of Topical R115866 Gel

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

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.

Study Overview

• Status: Completed
• Conditions: Cutaneous Inflammation
• Intervention / Treatment: Drug: Talarozole; Drug: Differin™, 0.1% adapalene gel

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, B-4000
    • Department of DermatopathologyCentre Hospitalier Universitaire du Sart Tilman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: A; No Treatment
Active Comparator: B; R115866 (0.35% gel)	Drug: Talarozole; Topical Application (20 mg); Other Names: Rambazole, R115866
Active Comparator: C; R115866 Vehicle gel	Drug: Talarozole; Topical Application (20 mg); Other Names: Rambazole, R115866
Active Comparator: D; Differin™, 0.1% adapalene gel	Drug: Differin™, 0.1% adapalene gel; Topical Application (20 mg); Other Names: adapalene gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary efficacy endpoint was the mean value of TEWL (Trans-epidermal water loss)	Day 1 through Day 9 of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Erythema	Day 1 through Day 8 of treatment and Day 15 post-treatment

Collaborators and Investigators

• Sponsor: Stiefel, a GSK Company
• Investigators: Principal Investigator: Prof. Dr. G. Piérard, MD, PhD, Department of Dermatopathology Centre Hospitalier Universitaire du Sart-Tilman

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: July 17, 2008
• First Submitted That Met QC Criteria: July 17, 2008
• First Posted (Estimate): July 21, 2008

Study Record Updates

• Last Update Posted (Estimate): September 26, 2011
• Last Update Submitted That Met QC Criteria: September 23, 2011
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Cytochrome P-450 Enzyme Inhibitors; R 115866; Adapalene
• Other Study ID Numbers: BT0700-107-BEL