Status:
COMPLETED
An Open Label Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment Facial Acne
Lead Sponsor:
Stiefel, a GSK Company
Conditions:
Acne
Eligibility:
MALE
16-50 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00725439
Start Date
September 1 2004
End Date
December 1 2007
Last Update
September 26 2011
Active Locations (3)
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1
Department of Dermatology, UZ Brussel
Brussels, Belgium, B-1090
2
Private Practice in Dermatology
Vilvoorde, Belgium, B-1800
3
Albert Schweitzer Hospital, Dermatology
Zwijndrecht, Netherlands, NL-3331 LZ