A randomised, double-blind, vehicle-controlled, parallel group, multicentre, proof of concept, phase II clinical study to investigate the efficacy and safety of 1 % FR260500 gel in patients with facial acne vulgaris - FR260500 proof of concept acne

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 66

Inclusion Criteria

•Patient has a diagnosis of mild to moderate facial acne vulgaris (up to 5 according to the Leeds revised acne grading system (O'Brien, Lewis, Cunliffe, 1998))
•Patient has at least 20 inflammatory lesions (pustules, papules), at least 20 non-inflammatory lesions (open and closed comedones), and 3 or less nodules above the mandibular line
•Patient is male or a surgically sterilised or post-menopausal female aged 16-40
•Willingness to actively participate in the study and to come to the scheduled visits
•Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study
•Additionally for persons younger than 18 years: signed written informed consent of both legal guardians (not required for United Kingdom)
•Willingness to discontinue the use of own cleansing and cosmetic products (e.g. soaps, creams, moisturizers and make-up) in the treatment area within 3 days before day 0 as well as during the course of the study

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Exclusion criteria related to wash-out:
—Patient has used any of the following: tretinoin/isotretinoin within the last 12 months before baseline; Diane®/Dianette® within the last 3 months before baseline; any other anti-acne medication or any oral antibiotics within the last 28 days before baseline; over-the-counter topical acne preparations in the face within the last 14 days before baseline
—Topical therapy of the face in the last two weeks that may interfere with the aim of the study, e.g. corticosteroids
—Any systemic treatment or the intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immunosuppressants, and antihistamines) within 28 days before start of the study. This does not include minor pain relief medicine, like aspirin or acidamidophene if not more than 500 mg per day are used.
•Patient has forms of facial acne other than acne vulgaris
•Patient intends to grow a beard during the study
•Moles, tattoos, pigmentation or scars on the face that would influence the visual assessment or lesion count
•Patient has any medical condition or disorder that precludes him/her from participating in the study in the opinion of the investigator
•Patient has a known allergy to components of the study drugs
•Use of sunbeds or UV-treatment or intense sun exposure during the study period or within two weeks before baseline
•Any history of drug addiction or alcoholism in the past 3 years
•Infectious diseases (e.g. hepatitis or AIDS)
•Patients with expected poor compliance
•Participation in a clinical trial concomitantly or within the last 30 days prior to the start of this study
•Patient has been previously randomised in this study
•Employees of the study sites or of the sponsor company

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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