Guidelines for clinical trials of frontal fibrosing alopecia: consensus recommendations from the International FFA Cooperative Group (IFFACG)*

Abstract

Summary 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.

Frontal fibrosing alopecia: survey of severity assessment methods in routine clinical practice and validation of the International Frontal Fibrosing Alopecia Cooperative Group measurement guidance

“…However, we also showed, for the first time to our knowledge, that measurement accuracy can be improved by providing simple guidance, as demonstrated in the clinical scenarios using the instruction ‘measure to the point where the hair density is most confluent and homogenous, ignoring lonely hairs’. This simple instruction significantly improved the inter‐rater variability for both frontal and temporal hairline measurements in this study and provides validation for the hairline definition and measurement strategy recommended by the IFFACG consensus 19 . This observation is important, as accurate outcome measures, consistently implemented across centres, will be vital for any future multicentre FFA clinical trial or registry.…”

“…This simple instruction significantly improved the inter-rater variability for both frontal and temporal hairline measurements in this study and provides validation for the hairline definition and measurement strategy recommended by the IFFACG consensus. 19 This observation is important, as accurate outcome measures, consistently implemented across centres, will be vital for any future multicentre FFA clinical trial or registry. Our work suggests that investigator training should be an important component of any such study.…”

“…For this final part, dermatologists were advised to 'measure to the point where the hair density is most confluent and homogenous, ignoring lonely hairs', a definition derived from the IFFACG work. 19…”

Refining the diagnosis and assessment methodology in frontal fibrosing alopecia

“…6 In many centres, systemic corticosteroids remain the firstline treatment for BP. 7 The ideal therapeutic dose has not been determined. Systemic corticosteroids such as prednisolone at dosages of 1 mg kg À1 per day are effective in treating severe disease; however, mortality and treatment-related adverse effects are more common.…”

Clinical and Dermoscopic Approaches to Diagnosis of Frontal Fibrosing Alopecia: Results From a Multicenter Study of the International Dermoscopy Society

“…Due to the lack of randomized clinical trials and lack of a control group in previous clinical studies, treatment of FFA is not evidence-based [21]. Lack of evidence doesn't mean, however, lack of effectiveness.…”