Study on Anti-inflammatory Effects of Topical R115866 Gel

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cutaneous Inflammation

Intervention / Treatment
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* Drug: Talarozole
* Drug: Differin™, 0.1% adapalene gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A<br>No Treatment | |
| Active Comparator: B<br>R115866 (0.35% gel) | Drug: Talarozole<br>* Topical Application (20 mg)<br>* Other names: Rambazole, R115866;|
| Active Comparator: C<br>R115866 Vehicle gel | Drug: Talarozole<br>* Topical Application (20 mg)<br>* Other names: Rambazole, R115866;|
| Active Comparator: D<br>Differin™, 0.1% adapalene gel | Drug: Differin™, 0.1% adapalene gel<br>* Topical Application (20 mg)<br>* Other names: adapalene gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy endpoint was the mean value of TEWL (Trans-epidermal water loss) |  | Day 1 through Day 9 of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema |  | Day 1 through Day 8 of treatment and Day 15 post-treatment |