Status:
COMPLETED
Study on Anti-inflammatory Effects of Topical R115866 Gel
Lead Sponsor:
Stiefel, a GSK Company
Conditions:
Cutaneous Inflammation
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00719121
Start Date
November 1 2006
End Date
March 1 2007
Last Update
September 26 2011
Active Locations (1)
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1
Department of DermatopathologyCentre Hospitalier Universitaire du Sart Tilman
Liège, Belgium, B-4000