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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00725439
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : September 26, 2011
Information provided by (Responsible Party):
GlaxoSmithKline ( 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.

Condition or disease Intervention/treatment Phase
Acne Drug: Talarozole Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: A
Drug: Talarozole
Oral Dose 1.0 mg once daily
Other Names:
  • Rambazole
  • R115866

Primary Outcome Measures :
  1. Facial Lesion Count [ Time Frame: Post 12 weeks treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00725439

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Department of Dermatology, UZ Brussel
Brussel, Belgium, B-1090
Private Practice in Dermatology
Vilvoorde, Belgium, B-1800
Albert Schweitzer Hospital, Dermatology
Zwijndrecht, Netherlands, NL-3331 LZ
Sponsors and Collaborators
Stiefel, a GSK Company
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Principal Investigator: Prof. Dr. D. Roseeuw, MD Department Dermatology, University Hospital Brussel (UZ Brussel)

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Responsible Party: Stiefel, a GSK Company Identifier: NCT00725439     History of Changes
Other Study ID Numbers: BT0700BEL001
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
R 115866
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action