Subjects with acne-prone skin aged 12-50 years with Investigator's Global Assessment (IGA) grades 2-4, evaluating treatment of mild to severe acne vulgaris. Skin and Connective Tissue Diseases
Conditions
Interventions
Multicentre, blinded, non-randomised, active-controlled, parallel-group real-world evidence study in participants aged 12-50 years with acne-prone skin (IGA grades 2-4). Participants receive either a
secondary outcomes include IGA score, participant satisfaction, quality of life, overall skin condition and safety.
Sponsors
Beiersdorf (Germany)
Eligibility
Sex/Gender
All
Age
12 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 12-50 years 2. Gender: Male, Female, Diverse 3. Phototype Fitzpatrick I-VI 4. Acne-prone skin with IGA grades 2-4 5. Generally healthy, with intact facial skin except for acne lesions 6. Willingness and ability to sign informed consent 7. Compliance with study rules and schedule
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Damaged facial skin (e.g., sunburn, eczema) 3. Use of topical antibiotics or benzoyl peroxide (BPO) during the study 4. Fungal acne 5. Chronic skin diseases, recent (4 weeks before study start) use of immunosuppressants, corticosteroids, or other treatments that could interfere with study outcomes 6. Any dermatological procedures (e.g., peeling, laser treatments) within 2 months prior to the study 7. Participation in any study within the last 3 months
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Investigator's Global Assessment (IGA) score measured using Dermatologist-assessed IGA acne severity score (0-4 scale) at Baseline and Week 8;Subject satisfaction with treatment, including product performance and satisfaction measured using subject self-assessment questionnaires at Week 8;Tolerability and safety measured using incidence and assessment of adverse events (AEs), serious adverse events (SAEs), and adverse product effects at Throughout the study (baseline to Month 12);Overall skin condition measured using Subject self-grading questionnaires of skin condition using rating scales at Baseline, Week 4, Week 8, and monthly during Months 3-12;Quality of life measured using Cardiff Acne Disability Index (CADI) and Eucerin Quality of Life (ELQI) questionnaires at Baseline, Week 4, Week 8, and monthly during Months 3-12 | — |
Primary
| Measure | Time frame |
|---|---|
| Acne lesion count measured using an objective dermatologist-assessed count of inflammatory and non-inflammatory acne lesions on the face at Baseline (week 0) and Week 8; primary endpoint assessed as change from baseline to Week 8 | — |
Countries
Austria, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Ecuador, England, France, Germany, Hungary, Italy, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Serbia, Slovakia, South Africa, Spain, Switzerland, Thailand, United Kingdom, Viet Nam
Contacts
Public ContactAnne-Christin Worthmann
Outcome results
None listed