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Study on Anti-inflammatory Effects of Topical R115866 Gel

NCT ID: NCT00719121

Last Updated: 2011-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-03-31

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.

Detailed Description

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Conditions

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Cutaneous Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Investigators

Study Groups

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A

No Treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

B

R115866 (0.35% gel)

Group Type ACTIVE_COMPARATOR

Talarozole

Intervention Type DRUG

Topical Application (20 mg)

C

R115866 Vehicle gel

Group Type ACTIVE_COMPARATOR

Talarozole

Intervention Type DRUG

Topical Application (20 mg)

D

Differin™, 0.1% adapalene gel

Group Type ACTIVE_COMPARATOR

Differin™, 0.1% adapalene gel

Intervention Type DRUG

Topical Application (20 mg)

Interventions

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Talarozole

Topical Application (20 mg)

Intervention Type DRUG

Differin™, 0.1% adapalene gel

Topical Application (20 mg)

Intervention Type DRUG

Other Intervention Names

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Rambazole, R115866 adapalene gel

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Stiefel, a GSK Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Dr. G. Piérard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatopathology Centre Hospitalier Universitaire du Sart-Tilman

Locations

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Department of DermatopathologyCentre Hospitalier Universitaire du Sart Tilman

Liège, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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BT0700-107-BEL

Identifier Type: -

Identifier Source: org_study_id