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

This study has been completed.
Sponsor:
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
  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:
  • Rambazole
  • R115866

  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 April 16, 2014