Mild to moderate facial acne vulgaris. MedDRA version: 7.0 Level: LLT Classification code 10000519
Conditions
Interventions
Product Code: FR260500
Pharmaceutical Form: Gel
CAS Number: 179170-18-4
Current Sponsor code: FR260500
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number:
Sponsors
Fujisawa GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy and safety of FR260500 gel 1% compared with the vehicle in the treatment of patients with facial acne vulgaris. The following four primary parameters will be analysed: •Reduction in the sum of inflammatory (pustules / papules) and non-inflammatory (open and closed comedones) lesions (total acne lesion count) from baseline to end of treatment •Reduction in the count of inflammatory lesions (pustules / papules) from baseline to end of treatment •Reduction in the count of non-inflammatory lesions (open and closed comedones) from baseline to end of treatment •Global Acne Score at the end of treatment Comparison between treatments will be performed for all parameters, without multiplicity adjustment. ;Secondary Objective: The secondary objectives will be: •investigation of the efficacy of the active drug group compared to the vehicle group with respect to percentage of patients discontinuing the study prematurely due to lack of efficacy, withdrawal of consent or lost to follow-up •analysis of subjective assessment by the patient •comparison of percentage lesion count change from baseline •comparison of lesion counts at separate intermediate time points •analysis of safety of the active drug group compared to the vehicle group ;Primary end point(s): The following four primary endpoints are defined: •Reduction in the sum of inflammatory (pustules / papules) and non-inflammatory (open and closed comedones) lesions (total acne lesion count) to end of treatment •Reduction in the count of inflammatory lesions (pustules / papules) to end of treatment •Reduction in the count of non-inflammatory lesions (open and closed comedones) to end of treatment •Global Acne Score at the end of treatment For these parameters comparisons between active drug group and vehicle group will be performed. Lesion counts will be used as dependent variables in linear models, adjusting for site and baseline lesion count. The proportion of responders (GAS = 1 | — |
Countries
Germany, United Kingdom
Outcome results
None listed