An Open Label Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment Facial Acne

Phase 2

Completed

• Conditions: Acne
• Interventions: Drug: Talarozole

• Registration Number: NCT00725439
• Lead Sponsor: Stiefel, a GSK Company

Brief Summary

This study is looking at a new oral drug to treat acne. All patients in the study will get active drug, there is no placebo arm.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2005-07
• Study Completion: 2007-12
• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-28
• Study First Posted: 2008-07-30
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-23
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• Male subject
• Presence of moderate to severe facial acne vulgaris: having a minimum of 15 papules and/or pustules and at least 2 nodulocystic lesions
• In good general health and free of any disease state or physical condition which, in the investigator's opinion, might have impaired evaluation of acne or exposed the subject to an unacceptable risk by trial participation

Exclusion Criteria

• Subjects with types of acne other than acne vulgaris
• Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV positive)
• History of any malignancy in the past 5 years, except for adequately treated basal cell carcinoma of the skin
• History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
• Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc >470 ms in females or >450 ms in males
• Use of vitamin A (>1000 microgram/day), phenytoin, carbamazepine, warfarin, rifampicin, tetracyclines, ketoconazole, itraconazole, astemizole, terfenadine, cisapride, anti-psychotics, anti-depressants, lithium, antimalarials, alpha-blocking drugs, angiotensin-converting enzyme inhibitors, cyclosporin A, glucocorticosteroids and non-steroid anti-inflammatory drugs, non-potassium-sparing diuretics
• Use of oral retinoids 6 months prior to Visit 1
• Use of other oral/topical therapy for acne unless stopped at Visit 1
• Use of ultraviolet light (including artificial UVA and UVB as well as excessive natural sun exposure) unless stopped at Visit 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Talarozole	Talarozole

Primary Outcome Measures

Name	Time	Method
Facial Lesion Count	Post 12 weeks treatment

Trial Locations

Locations (3)

Albert Schweitzer Hospital, Dermatology; 🇳🇱 Zwijndrecht, Netherlands

Department of Dermatology, UZ Brussel; 🇧🇪 Brussel, Belgium

Private Practice in Dermatology; 🇧🇪 Vilvoorde, Belgium