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

NCT ID: NCT00725439

Last Updated: 2011-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acne

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Talarozole

Group Type EXPERIMENTAL

Talarozole

Intervention Type DRUG

Oral Dose 1.0 mg once daily

Interventions

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Talarozole

Oral Dose 1.0 mg once daily

Intervention Type DRUG

Other Intervention Names

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Rambazole R115866

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Stiefel, a GSK Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Dr. D. Roseeuw, MD

Role: PRINCIPAL_INVESTIGATOR

Department Dermatology, University Hospital Brussel (UZ Brussel)

Locations

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Department of Dermatology, UZ Brussel

Brussels, , Belgium

Site Status

Private Practice in Dermatology

Vilvoorde, , Belgium

Site Status

Albert Schweitzer Hospital, Dermatology

Zwijndrecht, , Netherlands

Site Status

Countries

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Belgium Netherlands

Other Identifiers

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BT0700BEL001

Identifier Type: -

Identifier Source: org_study_id