Clindamycin, Tretinoin for Papulopustular acne

Inclusion criteria

• {"criterion_text":"- Women, men and adolescents of both sexes ≥ 12 and ≤ 65 years of age\n- Written consent to study participation after patient information by the investigator\n- 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\n- Diagnosis of papulopustular acne according to generally accepted criteria\n- 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\n- Investigator`s Global Assessment (IGA) of acne severity grade 2,3 or 4\n- For women of childbearing potential: Application of an established highly efficient contraceptive method during the whole study\n- For all female patients of childbearing potential: Urine pregnancy test with negative result prior to study start. The urine pregnancy test used must have a sensitivity down at least 25 mIU/ml for human chorionic gonadotrophin (hCG) (High sensitivity pregnancy test)"}

Exclusion criteria

• {"criterion_text":"- History or presence of Crohn`s disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis\n- 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)\n- 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\n- Other severe acute or chronic concomitant disease with severe impairment of the general condition\n- 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\n- Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data\n- Reasonable doubt concerning the co-operation of the patient\n- Participation in another clinical study within the last 30 days prior to inclusion in this study\n- Participation in this study at an earlier date\n- Women with existing or intended pregnancy or during lactation\n- 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)\n- Presence of pustular and deep cystic nodular acne lesions in the face (acne conglobata and acne fulminans)\n- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris\n- Presence of skin cancer in his/her own history\n- Known intolerance or hypersensitivity against clindamycin, tretinoin or lincomycin or any of the other ingredients in the study medication\n- 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)\n- 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\n- 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"}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Percent change from baseline (Day 0) to week 12 (Day 84) in inflammatory lesion count and percent change from baseline (Day 0) to week 12 (Day 84) in total lesion count."}

Secondary endpoints

• {"endpoint_text":"- Percent change from baseline (Visit 1) to Visit 8 (EoT) assessed by the non-inflammatory lesion count as well as the total lesion count","definition_or_measurement_approach":"Percent change from baseline (Visit 1) to Visit 8 (end of treatment) in non-inflammatory lesion count and total lesion count."}
• {"endpoint_text":"- Percent change in inflammatory lesion count, non-inflammatory lesion count and total lesion count between baseline (Visit 1) and Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7, respectively","definition_or_measurement_approach":"Percent change from baseline at each listed visit for inflammatory, non-inflammatory and total lesion counts."}
• {"endpoint_text":"- Absolute changes in inflammatory lesion count, non-inflammatory lesion count and total lesion count between baseline (Visit 1) and Visit 2, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7 and Visit 8, respectively","definition_or_measurement_approach":"Absolute change from baseline at each listed visit for inflammatory, non-inflammatory and total lesion counts."}
• {"endpoint_text":"- 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 Visit 8.","definition_or_measurement_approach":"Proportion of subjects achieving an Investigator's Global Assessment (IGA) improvement of ≥2 grades at Visit 8."}
• {"endpoint_text":"- Change of the Investigator`s Global Assessment (IGA) between baseline (Visit 1) and Visit 2, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7 and Visit 8, respectively. Changes will be calculated as baseline- follow-up.","definition_or_measurement_approach":"Change in IGA score from baseline to each listed visit, calculated as baseline minus follow-up."}
• {"endpoint_text":"- Evaluation of the overall therapeutic success by the investigator and patient at Visit 8","definition_or_measurement_approach":"Investigator and patient assessment of overall therapeutic success at Visit 8 (method as per protocol)."}
• {"endpoint_text":"- Incidence of adverse events (AEs) during the course of the study","definition_or_measurement_approach":"Recording and analysis of adverse event incidence during study period."}
• {"endpoint_text":"- Evaluation of tolerability by the investigator and by the patient from Visit 2 to Visit 8 (EoT)","definition_or_measurement_approach":"Investigator and patient assessments of tolerability at Visits 2–8."}

Germany

Earliest CTIS Part Ii Submission Date

03-04-2024

Latest Decision Or Authorization Date

27-04-2026

Processing Time Days

754

Number Of Sites

13

Number Of Participants

675

Primary sponsor

Full Name

Dermapharm AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

GKM Gesellschaft fuer Therapieforschung mbH

Responsibilities

sponsorDuties codes: 10,11,6,7; contact: science@gkm-therapieforschung.de

Name

Symbio Clinical Research GmbH

Responsibilities

sponsorDuties codes: 1,2; contact: information@symbioresearch.com

Third parties

• {"country":"Germany","full_name":"GKM Gesellschaft fuer Therapieforschung mbH","duties_or_roles":"sponsorDuties codes: 10,11,6,7","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Symbio Clinical Research GmbH","duties_or_roles":"sponsorDuties codes: 1,2","organisation_type":"Pharmaceutical company"}