Trial | NCT00719121  Report issue

Title

Study on Anti-inflammatory Effects of Topical R115866 Gel
Placebo-Controlled, Investigator Blinded, Explorative Trial to Evaluate the Anti-inflammatory Effect of Multiple Topical Applications of R115866 Gel (0.35%) in Two Models of Cutaneous Inflammation in Healthy Male Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    12
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.
Study Started
Nov 30
2006
Primary Completion
Dec 31
2006
Study Completion
Mar 31
2007
Last Update
Sep 26
2011
Estimate

Drug Talarozole

Topical Application (20 mg)

  • Other names: Rambazole, R115866

Drug Differin™, 0.1% adapalene gel

Topical Application (20 mg)

  • Other names: adapalene gel

A No Intervention

No Treatment

B Active Comparator

R115866 (0.35% gel)

C Active Comparator

R115866 Vehicle gel

D Active Comparator

Differin™, 0.1% adapalene gel

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
No Results Posted