Clinical study to compare two gels with the active substances clindamycin and benzoylperoxid and one gel without active substance for patients with papulopustular acne
- Conditions
- Papulopustular acneMedDRA version: 21.0Level: LLTClassification code 10000506Term: Acne follicular papular pustular etcSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-000522-36-DE
- Lead Sponsor
- Dermapharm AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 675
• 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 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: 675
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) yes
F.1.3.1 Number of subjects for this age range
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of the efficacy and safety of a new gel containing 10 mg/g Clindamycin and 50 mg/g Benzoyl peroxide vs. the orginator DUAC(R) Akne 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);Timepoint(s) of evaluation of this end point: Start of therapy (Day 0) and end of therapy (Visit 5)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Percent change from baseline to week 12 in the non-inflammatory lesion counts<br>• Absolute changes in inflammatory lesion count, non-inflammatory lesion count and total lesion count between visits<br>• Proportion of subjects with a clinical response of success”, i.e. an IGA score of at least 2 grades less than the baseline assessment, at week 12<br>• Change of the Investigator`s Global Assessment (IGA) between visits <br>• Evaluation of Overall Therapeutic Success by the investigator and patient at the final examination<br>• Number and classification of adverse events<br>• Evaluation of tolerability by the investigator and by the patient at Visit 2 – Visit 8.<br>;Timepoint(s) of evaluation of this end point: Depends on the secondary endpoint, see E.5.2 above