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

Acne Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725439
• Other study ID #: BT0700BEL001
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2008
• Last updated: September 23, 2011
• Start date: September 2004
• Est. completion date: December 2007

Study information

• Verified date: September 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2007
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne

Intervention

Drug:
• Talarozole
Oral Dose 1.0 mg once daily

Locations

Country	Name	City	State
Belgium	Department of Dermatology, UZ Brussel	Brussel
Belgium	Private Practice in Dermatology	Vilvoorde
Netherlands	Albert Schweitzer Hospital, Dermatology	Zwijndrecht

Sponsors (1)

Lead Sponsor	Collaborator
Stiefel, a GSK Company

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial Lesion Count		Post 12 weeks treatment	No