Trifaroten (1) – Selgamis®
Acne vulgaris, ≥ 12 years
Characteristics
| Start date | 15.08.2020 – Marketing authorisation: 15.04.2020 |
|---|---|
| Resolution | 04.02.2021 |
| INN | Trifaroten |
| Brand name | Selgamis® |
| Pharm. company | Galderma Laboratorium GmbH |
| G-BA Procedure ID | D-572 |
| ATC code | D10AD06 Retinoids for topical use in acne (D10AD) |
| DDD | 50 mcg T |
| Therapeutic area | Skin diseases |
| Reason for procedure | Initial assessment |
Studies and Results
- Clinical trials
- The double-blind, placebo-controlled trials PERFECT-1 and PERFECT-2 investigate the efficacy and safety of trifaroten in patients aged 9 years and over with acne vulgaris, compared with placebo, over a period of 12 weeks.
- The single-arm SATISFY trial investigates the treatment with Trifaroten in the indicated therapeutic indication over 52 weeks.
Patients aged 12 years and over with acne vulgaris on the face and/or trunk, where there are numerous comedones, papules and pustules
- For patients aged 12 years and over with acne vulgaris on the face and/or trunk, where there are numerous comedones, papules and pustules, the additional benefit is not proven.
- Due to the lack of a comparison with the appropriate comparator therapy, neither the placebo-controlled studies PERFECT-1 and PERFECT-2 nor the single-arm SATISFY study are suitable for the benefit assessment in accordance with Section 35a of the German Social Code, Book V (SGB V).
- Overall, it is concluded that the additional benefit of trifarotene is not proven in patients aged twelve years and over with acne vulgaris on the face and/or trunk, where numerous comedones, papules and pustules are present.
Courtesy translation only, please refer to the German original.
Associated procedures
| Trifaroten (1) | Selgamis® | Galderma Laboratorium GmbH | Acne vulgaris, ≥ 12 years | 887,500–1,950,700 | 100% additional benefit not proven |
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