Study on Anti-inflammatory Effects of Topical R115866 Gel

Stiefel

Status and phase: Completed; Phase 1

Conditions: Cutaneous Inflammation

Treatments: Drug: Talarozole; Drug: Differin™, 0.1% adapalene gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00719121

BT0700-107-BEL

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

12 participants in 4 patient groups

A

No Intervention group

Description:

No Treatment

B

Active Comparator group

Description:

R115866 (0.35% gel)

Treatment:

Drug: Talarozole

C

Active Comparator group

Description:

R115866 Vehicle gel

Treatment:

Drug: Talarozole

D

Active Comparator group

Description:

Differin™, 0.1% adapalene gel

Treatment:

Drug: Differin™, 0.1% adapalene gel