Study on Anti-inflammatory Effects of Topical R115866 Gel

Phase 1

Completed

• Conditions: Cutaneous Inflammation
• Interventions: Drug: Differin™, 0.1% adapalene gel; Drug: Talarozole

• Registration Number: NCT00719121
• Lead Sponsor: Stiefel, a GSK Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2006-12
• Study Completion: 2007-03
• Status Verified: 2008-07
• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-17
• Study First Posted: 2008-07-21
• Last Update Submitted: 2011-09-23
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
D	Differin™, 0.1% adapalene gel	Differin™, 0.1% adapalene gel
C	Talarozole	R115866 Vehicle gel
B	Talarozole	R115866 (0.35% gel)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Erythema	Day 1 through Day 8 of treatment and Day 15 post-treatment

Trial Locations

Locations (1)

Department of DermatopathologyCentre Hospitalier Universitaire du Sart Tilman; 🇧🇪 Liege, Belgium