Population and study design
mycosis, alopecia areata, ±, psoriasis, Hair loss, allergies, FAGA
HAIR THINNING, MYCOSIS, ALOPECIA AREATA, PSORIASIS, MAY, THINNING HAIR, IRON DEFICIENCY, HAIR LOSS, ALLERGIES, SEBORRHEIC DERMATITIS, LUDWIG
Between May 2022 and November 2022, 83 subjects with AGA, FAGA or chronic TE were assessed and screened for inclusion in the trial. Hair loss condition was confirmed by physical examination performed by a dermatologist that assigned a clinical diagnosis of AGA or chronic TE. AGA was diagnosed using the Hamilton or Ludwig scales by observing hair thinning and miniaturization in scalp region. Chronic TE was diagnosed considering subject history, self‐reported and investigator‐reported thinning hair. The study was designed as a 12‐week, prospective, randomized, assessor‐blinded trial. The trial took place in six different Dermatology clinics in Italy. The trial was conducted according to Good Clinical Practice Guidelines and Helsinki Declaration. All subjects provided signed informed consent. Eighty‐three subjects (mean age 41.2 ± 16.2 years) with AGA/FAGA (71.1%) or TE (28.9%) were enrolled. The main inclusion criteria were age >18 years, diagnosis of AGA/FAGA or chronic TE, eligible for the treatment with the oral supplement used in the study. The main exclusion criteria were acute inflammatory condition at the scalp, allergies to the components of the products used in the study, iron deficiency, clinically relevant alteration to thyroid function, presence of other scalp conditions (e.g., alopecia areata, seborrheic dermatitis, psoriasis, mycosis, lichenoid lesions). The study was conducted over 12 weeks, patients was evaluated at baseline and after 6 (facultative visit) and 12 weeks. Patients were randomly divided in two arms: Group A (