An Open Label Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment Facial Acne
This study has been completed.
Sponsor:
Stiefel, a GSK Company
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00725439
First received: July 17, 2008
Last updated: September 23, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne |
Drug: Talarozole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Pilot Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment of Moderate to Severe Facial Acne |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Facial Lesion Count [ Time Frame: Post 12 weeks treatment ] [ Designated as safety issue: No ]
| Enrollment: | 16 |
| Study Start Date: | September 2004 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Talarozole
|
Drug: Talarozole
Oral Dose 1.0 mg once daily
Other Names:
|
Eligibility| Ages Eligible for Study: | 16 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725439
Locations
| Belgium | |
| Department of Dermatology, UZ Brussel | |
| Brussel, Belgium, B-1090 | |
| Private Practice in Dermatology | |
| Vilvoorde, Belgium, B-1800 | |
| Netherlands | |
| Albert Schweitzer Hospital, Dermatology | |
| Zwijndrecht, Netherlands, NL-3331 LZ | |
Sponsors and Collaborators
Stiefel, a GSK Company
Investigators
| Principal Investigator: | Prof. Dr. D. Roseeuw, MD | Department Dermatology, University Hospital Brussel (UZ Brussel) |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline ( Stiefel, a GSK Company ) |
| ClinicalTrials.gov Identifier: | NCT00725439 History of Changes |
| Other Study ID Numbers: | BT0700BEL001 |
| Study First Received: | July 17, 2008 |
| Last Updated: | September 23, 2011 |
| Health Authority: | Belgium: Federal Agency for Medicines and Health Products, FAMHP |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases |
ClinicalTrials.gov processed this record on June 13, 2013