Cutaneous Inflammation
Conditions
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.
Interventions
DRUGTalarozole
Topical Application (20 mg)
DRUGDifferin™, 0.1% adapalene gel
Topical Application (20 mg)
Sponsors
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint was the mean value of TEWL (Trans-epidermal water loss) | Day 1 through Day 9 of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Erythema | Day 1 through Day 8 of treatment and Day 15 post-treatment |
Countries
Belgium
Outcome results
None listed