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

NCT00725439 | Completed Phase 2

• 1 other identifier: BT0700BEL001
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 3

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• Facial Lesion Count

  Post 12 weeks treatment

Study Arms (1)

A

EXPERIMENTAL

Talarozole

Drug: Talarozole

Interventions

Talarozole DRUG

Oral Dose 1.0 mg once daily

Also known as: Rambazole, R115866

A

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stiefel, a GSK Company: lead

Study Sites (3)

Department of Dermatology, UZ Brussel

Brussels, B-1090, Belgium

Location

Private Practice in Dermatology

Vilvoorde, B-1800, Belgium

Location

Albert Schweitzer Hospital, Dermatology

Zwijndrecht, NL-3331 LZ, Netherlands

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

R 115866

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Prof. Dr. D. Roseeuw, MD

  Department Dermatology, University Hospital Brussel (UZ Brussel)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2008
• First Posted: July 30, 2008
• Study Start: September 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: December 1, 2007
• Last Updated: September 26, 2011

Record last verified: 2011-09

Locations

BE (2); NL (1)