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Study on Anti-inflammatory Effects of Topical R115866 Gel
Study on Anti-inflammatory Effects of Topical R115866 Gel

NCT00719121

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