Trifarotene in moderate acne: No study data for the assessment of the added benefit
Trifarotene is a drug for the external treatment of acne vulgaris of the face and trunk. It is suitable for affected people with many comedones, papules and pustules, i.e. with moderate acne for which systemic therapy is not yet an option.
The Federal Joint Committee (G-BA) now commissioned the German Institute for Quality and Efficiency in Health Care (IQWiG) to investigate whether the drug offers these patients aged twelve years and older an added benefit in comparison with combination therapy of adapalene and benzoyl peroxide or of clindamycin and benzoyl peroxide, which is also applied externally.
As the drug manufacturer's dossier did not contain any study data suitable for a direct or indirect comparison with this appropriate comparator therapy, it was concluded that an added benefit of trifarotene is not proven.
Placebo-controlled approval studies
The manufacturer cited two randomized controlled trials from the approval process in which trifarotene was compared with placebo, so they cannot be used for comparison with an established treatment alternative. In addition, the treatment phases of 12 weeks were very short. For a chronic condition like acne vulgaris, a minimum of 24 weeks is needed for a benefit assessment. The dossier contained supplementary information on a 1-year study, but this study had no control arm.
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