Guidelines for clinical trials of frontal fibrosing alopecia: consensus recommendations from the International FFA Cooperative Group (IFFACG).
BACKGROUND: Frontal fibrosing alopecia (FFA) has become one of the most common causes of cicatricial alopecia worldwide. However, there is a lack of clear aetiology and robust clinical trial evidence for the efficacy and safety of agents currently used for treatment. OBJECTIVES: To enable data to be collected worldwide on FFA using common criteria and assessment methods. METHODS: A multicentre, international group of experts in hair loss was convened by email to create consensus recommendations for clinical trials. Consensus was defined at > 90% agreement on each recommended part of these guidelines. RESULTS: Standardized diagnostic criteria, severity rating, staging, and investigator and patient assessment of scalp hair loss and other clinical features of FFA were created. CONCLUSIONS: These guidelines should allow the collection of reliable aggregate data on FFA and advance efforts in both clinical and basic research to close knowledge gaps in this condition.
Olsen, EA; Harries, M; Tosti, A; Bergfeld, W; Blume-Peytavi, U; Callender, V; Chasapi, V; Correia, O; Cotsarelis, G; Dhurat, R; Dlova, N; Doche, I; Enechukwu, N; Grimalt, R; Itami, S; Hordinsky, M; Khobzei, K; Lee, W-S; Malakar, S; Messenger, A; McMichael, A; Mirmirani, P; Ovcharenko, Y; Papanikou, S; Pinto, GM; Piraccini, BM; Pirmez, R; Reygagne, P; Roberts, J; Rudnicka, L; Saceda-Corralo, D; Shapiro, J; Silyuk, T; Sinclair, R; Soares, RO; Souissi, A; Vogt, A; Washenik, K; Zlotogorski, A; Canfield, D; Vano-Galvan, S
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