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Study on Anti-inflammatory Effects of Topical R115866 Gel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00719121
First received: July 17, 2008
Last updated: September 23, 2011
Last verified: July 2008
History of Changes
  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 1

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 May 23, 2013