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Study on Anti-inflammatory Effects of Topical R115866 Gel
Study on Anti-inflammatory Effects of Topical R115866 Gel
CompletedPhase 1
Sponsor: Stiefel, a GSK Company
Conditions: Cutaneous Inflammation
Interventions: Talarozole, Differin™, 0.1% adapalene gel
Countries: Belgium
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.
Eligibility overview
Sex: MALE
Age: 18 Years to 55 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Eligibility 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
Locations (1)
- Liège, Belgium