Papulopustular acne MedDRA version: 21.0 Level: LLT Classification code 10000506 Term: Acne follicular papular pustular etc System Organ Class: 100000004858
Conditions
Interventions
Product Name: Clindamycin/Benzoyl Peroxide Gel (10 mg/g + 30 mg/g)
Pharmaceutical Form: Gel
INN or Proposed INN: Clindamycin Phosphate
CAS Number: 24729-96-2
Current Sponsor code: n.a.
Other descripti
Sponsors
Dermapharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Women, men and adolescents of both sexes = 12 years of age ? Written consent to study participation after patient information by the investigator ? In case of patients below the age of 18: Written consent to study participation of legal guardian(s) and adolescent patient after an age-appropriate patient- and legal guardian(s)- information session by the investigator ? Diagnosis of papulopustular acne according to generally accepted criteria ? On the face, = 25 non-inflammatory lesions (i.e. open and closed comedones) and = 20 inflammatory lesions (e.g. papules and pustules), thereof = 2 nodular lesions ? Investigator`s Global Assessment (IGA) of acne severity grade 2,3 or 4 ? For women and girls of childbearing potential: Application of an highly efficient contraceptive method during the whole study ? For all female patients of childbearing potential: Pregnancy test with negative result prior to study start Are the trial subjects under 18? yes Number of subjects for this age range: 220 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 435 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? History or presence of Crohn`s disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis. ? Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis) ? Presence of cystic acne lesions in the face ? Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris ? Known intolerance or hypersensitivity against benzoyl peroxide or clindamycin or any of the other ingredients in the study medication ? Use within 6 months prior to baseline of oral retinoids (e.g. isotretinoine) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed). ? Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy, when taken, must remain constant throughout the study. ? Use on the face within 30 days prior baseline or during the study of 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy. ? Use within 30 days prior to baseline of: 1) spironolactone, 2) systemic glucocorticoids, 3) systemic antibiotics or 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-months washout) ? Use within 14 days prior to baseline in the face of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents or 5) topical antibiotics. ? Other severe acute or chronic concomitant disease with severe impairment of the general condition ? Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible ? Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data ? Reasonable doubt concerning the co-operation of the patient ? Participation in another clinical study within the last 30 days prior to inclusion in this study ? Participation in this study at an earlier date ? Women with existing or intended pregnancy or during lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 84;Main Objective: Evaluation of the efficacy and safety of a new gel containing 10 mg/g Clindamycin and 30 mg/g Benzoyl peroxide vs. the orginator DUAC(R) 10 mg/g + 30 mg/g Gel (Reference) vs. vehicle in patients with papulopustular acne;Secondary Objective: see E5 (endpoints);Primary end point(s): Primary efficacy endpoints to be analysed are the percent change in inflammatory lesion count from baseline (Day 0) to week 12 (Day 84) as well as the percent change in total lesion count from baseline (Day 0) to week 12 (Day 84). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Planned secondary endpoints are, among others, the absolute changes in inflammatory, non-inflammatory and total lesion count between each visit as well as the proportion of subjects with a clinical response of “success” at week 12. “Success” is thereby defined as an IGA score that has to be at least 2 grades less than the baseline assessment. Another secondary endpoint is the overall therapeutic success evaluated by investigator and patients at the EOT visit.;Timepoint(s) of evaluation of this end point: Week 12, Depends on the secondary endpoint, see E.5.2 above | — |
Countries
Czech Republic
Contacts
Public ContactPharmnet s.r.o.
Pharmnet s.r.o.
Outcome results
None listed