Evaluation of the efficacy and safety of a new gel containing 10 mg/g Clindamycin and 0.25 mg/g Tretinoin vs. the originator Acnatac(R) 10 mg/g + 0.25 mg/Gel (Reference) vs. vehicle in patients with papulopustular acne

Phase 1

Recruiting

• Conditions: Papulopustular acne; MedDRA version: 21.0Level: LLTClassification code: 10000506Term: Acne follicular papular pustular etc Class: 10040785; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2023-504552-10-01
• Lead Sponsor: Dermapharm AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-27
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 675

Inclusion Criteria

Women, men and adolescents of both sexes = 12 and = 65 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 of childbearing potential: Application of an established highly efficient contraceptive method during the whole study, 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

History or presence of Crohn`s disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis, 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, 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 pustular and deep cystic nodular acne lesions in the face (acne conglobata and acne fulminans), Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris, Presence of skin cancer in his/her own history, Known intolerance or hypersensitivity against clindamycin, tretinoin or lincomycin 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified