Overview

Study on Anti-inflammatory Effects of Topical R115866 Gel

Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Stiefel, a GSK Company
Treatments:
Adapalene
Anti-Inflammatory Agents
R 115866
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