Study on Anti-inflammatory Effects of Topical R115866 Gel - Full Text View

Sponsor:	Stiefel, a GSK Company
Information provided by (Responsible Party):	GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:	NCT00719121

Purpose

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.

Condition	Intervention	Phase
Cutaneous Inflammation	Drug: Talarozole Drug: Differin™, 0.1% adapalene gel	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator)
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Adapalene

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Primary efficacy endpoint was the mean value of TEWL (Trans-epidermal water loss) [ Time Frame: Day 1 through Day 9 of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Erythema [ Time Frame: Day 1 through Day 8 of treatment and Day 15 post-treatment ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	November 2006
Study Completion Date:	March 2007
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: A No Treatment
Active Comparator: B R115866 (0.35% gel)	Drug: Talarozole Topical Application (20 mg) Other Name: Rambazole, R115866
Active Comparator: C R115866 Vehicle gel	Drug: Talarozole Topical Application (20 mg) Other Name: Rambazole, R115866
Active Comparator: D Differin™, 0.1% adapalene gel	Drug: Differin™, 0.1% adapalene gel Topical Application (20 mg) Other Name: adapalene gel

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719121

Locations

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

Sponsors and Collaborators

Stiefel, a GSK Company

Investigators

Principal Investigator:

Prof. Dr. G. Piérard, MD, PhD

Department of Dermatopathology Centre Hospitalier Universitaire du Sart-Tilman

More Information

No publications provided

Responsible Party:	GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:	NCT00719121 History of Changes
Other Study ID Numbers:	BT0700-107-BEL
Study First Received:	July 17, 2008
Last Updated:	September 23, 2011
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Inflammation
Pathologic Processes
Adapalene
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012