Acne vulgaris (AV)
Conditions
Interventions
Trade Name: Benzaknen® 5% Gel
Product Name: Benzaknen® 5% Gel
Product Code: 1858.00.00
Pharmaceutical Form: Gel
INN or Proposed INN: Benzoylperoxid
Other descriptive name: BENZOYL PEROXIDE
Concentra
Sponsors
Galderma R&D
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible for the study, subjects must fulfil all of the following criteria: 1. Male or female subject of any ethnic background of 12 years or older, 2. Subject with mild or moderate facial acne vulgaris (IGA 2 or 3), Investigator’s Global Assessment: 0 - Clear - Residual hyperpigmentation and erythema may be present 1 - Almost Clear - A few scattered comedones and a few small papules 2 - Mild - Some comedones and some papules and pustules. No nodules present 3 - Moderate - Many comedones, papules and pustules. 4 - Severe - Covered with comedones, numerous papules and pustules and a few nodules may be present 3. Subject with any skin phototype (according to T.B. Fitzpatrick skin phototype definitions*) 4. Female of childbearing potential with a negative Urine Pregnancy Test (UPT) at Baseline must practice a highly effective method of contraception during the study: oral /systemic (injectable, patch, etc.) contraception (must have been on stable dose for 3 months prior to study entry), bilateral tubal ligation, hormonal intrauterine device (IUD) inserted at least 1 month prior to Baseline, strict abstinence, or partner had a vasectomy, 5. Female of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 1 years), hysterectomy, or bilateral oophorectomy are not required to have a UPT at Baseline, 6. Subject (or the parents/legal representative for subjects age under 18) willing and capable of complying with the extent and degree required by the protocol, 7. Subject (or the parents/legal representative for subjects age under 18) having read and signed the approved Informed Consent Form prior to any participation in the study. Subjects under the age of 18 must sign an assent form to participate in the study and they must have one parents or guardian read and sign the Informed Consent Form prior to any study related procedures, 8. Subject must be willing to be photographed. Subject (and parents/guardian if subject is under 18 years of age) must be willing to sign a Photography Release Consent Form. Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any subject who meets one or more of the following criteria will not be eligible for the study: 1. Subject with severe acne (IGA>3) with nodules, cysts, scars or extra-facial lesions, 2. Female subject who is pregnant, lactating or planning a pregnancy during the study, 3. Female Taking Diane-35, 4. Subject with an acute or chronic disease that could interfere with study results, 5. Subject susceptible to take a corticosteroid treatment during the study except inhaled or topic when needed to treat a condition outside the face, 6. Subject with a dermatologic condition on the face other than acne that might put the subject at risk or interfere with study evaluations, 7. Subject using another facial cosmetic product than the one received for this study 8. Subject with acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.), 9. Subject with a wash-out period for topical treatment or procedures on the face less than: Topical treatments: Corticosteroids, antibiotics, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments 2 weeks Medical Procedures: laser resurfacing, deep chemical peel, plastic surgery 12 months Cosmetic procedure (e.g., facials, superficial peels, blue light, comedone extraction, microdermabrasion) on facial areas 4 weeks 10. Subject with a wash-out period for systemic treatment less than (see table below): Corticosteroids, tetracyclines, other antibiotics 4 weeks Oral isotretinoin 6 months Ciproterone acetate 2 months Spironolactone 2 months 11. Subject with active or chronic skin allergies, 12. Subject with known or suspected allergy to the investigational product (see package insert), 13. Subject with damaged facial skin (e.g., sunburn, tattoo, or scar), 14. Subject who foresees intensive UV exposure during the study (mountain sports, sailing, sunbathing, etc), 15. Subject with a history of photosensitivity, 16. Subject who is at risk in terms of precautions, warnings, and contraindications (see package insert), 17. Subject with a beard or other facial hair that might interfere with study assessments, 18. Subject with a history of major medical or psychiatric condition or surgical interventions that, in the opinion of the investigator, might put the subject at risk, 19. Subject under guardianship, hospitalized subject in a public or private institution for a reason other than the research, and subject deprived of his/her freedom, 20. Subject who has participated in another investigational drug or device research study within 30 days prior to enrolment. 21. Subject who is employee of the study site or of the sponsors company.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate subject satisfaction with the treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30 after 12 weeks of treatment. The safety and efficacy of this treatment regimen will also be evaluated.;Secondary Objective: not applicable;Primary end point(s): Patients satisfaction, evaluated by patient satisfaction questionnaire;Timepoint(s) of evaluation of this end point: Week 12/Early termination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) • Percent change from Baseline in inflammatory lesion count • Percent change from Baseline in non-inflammatory lesion count • Global Assessment of Improvement from Baseline: % of subjects across scores Safety variables • Incidence of Adverse Events, • Local tolerability worst-score post Baseline: % of subjects across scores, Other •Percent change from Baseline in number of orange fluorescent pixels with UV fluorescence photography. ;Timepoint(s) of evaluation of this end point: Each study visit | — |
Countries
Germany
Contacts
Public ContactStéphanie Leclerc
Galderma R&D
Outcome results
None listed