Study on Anti-inflammatory Effects of Topical R115866 Gel

Cutaneous Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719121
• Other study ID #: BT0700-107-BEL
• Status: Completed
• Phase: Phase 1
• First received: July 17, 2008
• Last updated: September 23, 2011
• Start date: November 2006
• Est. completion date: March 2007

Study information

• Verified date: July 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Cutaneous Inflammation
• Dermatitis
• Inflammation

Intervention

Drug:
• Talarozole
Topical Application (20 mg)
• Differin™, 0.1% adapalene gel
Topical Application (20 mg)

Locations

Country	Name	City	State
Belgium	Department of DermatopathologyCentre Hospitalier Universitaire du Sart Tilman	Liege

Sponsors (1)

Lead Sponsor	Collaborator
Stiefel, a GSK Company

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy endpoint was the mean value of TEWL (Trans-epidermal water loss)		Day 1 through Day 9 of treatment	No
Secondary	Erythema		Day 1 through Day 8 of treatment and Day 15 post-treatment	No