Study on Anti-inflammatory Effects of Topical R115866 Gel

NCT00719121 | Completed Phase 1

• 1 other identifier: BT0700-107-BEL
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Inflammation

Outcome Measures

Primary Outcomes (1)

• Primary efficacy endpoint was the mean value of TEWL (Trans-epidermal water loss)

  Day 1 through Day 9 of treatment

Secondary Outcomes (1)

• Erythema

  Day 1 through Day 8 of treatment and Day 15 post-treatment

Study Arms (4)

A

NO INTERVENTION

No Treatment

B

ACTIVE COMPARATOR

R115866 (0.35% gel)

Drug: Talarozole

C

ACTIVE COMPARATOR

R115866 Vehicle gel

Drug: Talarozole

D

ACTIVE COMPARATOR

Differin™, 0.1% adapalene gel

Drug: Differin™, 0.1% adapalene gel

Interventions

Talarozole DRUG

Topical Application (20 mg)

Also known as: Rambazole, R115866

B; C

Differin™, 0.1% adapalene gel DRUG

Topical Application (20 mg)

Also known as: adapalene gel

D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stiefel, a GSK Company: lead

Study Sites (1)

Department of DermatopathologyCentre Hospitalier Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

MeSH Terms

Conditions

Dermatitis

Interventions

R 115866; Adapalene

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Prof. Dr. G. Piérard, MD, PhD

  Department of Dermatopathology Centre Hospitalier Universitaire du Sart-Tilman

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2008
• First Posted: July 21, 2008
• Study Start: November 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: March 1, 2007
• Last Updated: September 26, 2011

Record last verified: 2008-07

Locations

BE (1)