We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Study on Anti-inflammatory Effects of Topical R115866 Gel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00719121
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : September 26, 2011
Information provided by (Responsible Party):
GlaxoSmithKline ( 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.

Condition or disease Intervention/treatment Phase
Cutaneous Inflammation Drug: Talarozole Drug: Differin™, 0.1% adapalene gel Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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
Study Start Date : November 2006
Primary Completion Date : December 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Adapalene
U.S. FDA Resources

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Erythema [ Time Frame: Day 1 through Day 8 of treatment and Day 15 post-treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719121

Department of DermatopathologyCentre Hospitalier Universitaire du Sart Tilman
Liege, Belgium, B-4000
Sponsors and Collaborators
Stiefel, a GSK Company
Principal Investigator: Prof. Dr. G. Piérard, MD, PhD Department of Dermatopathology Centre Hospitalier Universitaire du Sart-Tilman

Responsible Party: Stiefel, a GSK Company
ClinicalTrials.gov Identifier: NCT00719121     History of Changes
Other Study ID Numbers: BT0700-107-BEL
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: July 2008

Additional relevant MeSH terms:
Pathologic Processes
Skin Diseases
Anti-Inflammatory Agents
R 115866
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Dermatologic Agents
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action