Trial | NCT00725439  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Acne

  • Intervention/Treatment

    talarozole ...

  • Study Participants

    16
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.
Study Started
Sep 30
2004
Primary Completion
Jul 31
2005
Study Completion
Dec 31
2007
Last Update
Sep 26
2011
Estimate

Drug Talarozole

Oral Dose 1.0 mg once daily

  • Other names: Rambazole, R115866

A Experimental

Talarozole

Criteria 

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
No Results Posted