Evaluation of a dermocosmetic regimen for acne-prone skin in volunteers with mild, moderate or severe skin conditions

Evaluation of a dermocosmetic regimen for acne-prone skin in volunteers with IGA Grades 2-4

Registry ID
ISRCTN12623932
Source registry
ISRCTN
Status
No longer recruiting
Study type
INTERVENTIONAL
Sponsor
Beiersdorf (Germany)
Enrollment
3100
Start date
2025-03-13
Completion date
2026-09-30
Last update
2026-08-17

Conditions

Summary

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.

Detailed description

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 DermoPure Probiotic Kit-based dermocosmetic regimen plus sun protection or an active control skincare regimen. Clinical assessments are conducted at baseline and week 8, with participant questionnaires completed at baseline, week 4, week 8 and monthly until month 12. The primary outcome is change in acne lesion count; secondary outcomes include IGA score, participant satisfaction, quality of life, overall skin condition and safety.

Interventions

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

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

Locations

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