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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
  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:


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
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, see Learn About Clinical Studies.

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: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Dermatitis
Inflammation
Pathologic Processes
Skin Diseases
Adapalene
Anti-Inflammatory Agents
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014