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) |
| ICD-10 codes (AIS) | L70.0Acne vulgaris |
| Alpha-ID codes (AIS) | I12299Acne vulgaris |
| DDD | 50 mcg T |
| Therapeutic area | Skin diseases Acne vulgaris |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Trifaroten is indicated for the topical treatment of acne vulgaris on the face and/or trunk in patients 12 years of age and older if many comedones, papules, and pustules are present. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Patients aged twelve years and over with acne vulgaris on the face and / or trunk when many comedones, papules and pustules are present. | - a topical combination therapy of adapalene + benzoyl peroxide or - a topical combination therapy of clindamycin + benzoyl peroxide |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
- 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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