Efficacy and Tolerability of a Topical Gel Containing Mimicking Growth Factors Oligopeptides, Caffeine, Taurine and an Iron-Chelating Complex in Subjects with Androgenetic Alopecia Treated with Topical Minoxidil or Oral Finasteride: a Prospective, 6-Month, Randomized, Assessor-Blinded, 4-Arm, Parallel Group Study

Introduction: Topical minoxidil and oral finasteride are the first-line pharmacological treatments for Androgenic Alopecia (AGA).However, adjuvant strategies with non-pharmacological products could increase their clinical efficacy.A topical gel containing oligopeptides with growth-factor mimicking activity, caffeine, taurine, and a lactoferrin-based iron-chelating complex has been recently available (GFM-DA gel).Study Aim: We evaluated in a prospective, randomized, 4-arm, assessor-blinded, 6-month trial the efficacy of the GFM-DA as add-on treatment (one 12.5 ml application once a week) in subjects with AGA using topical 5% minoxidil (T-MNX), 1 ml twice daily, or oral 1 mg daily finasteride (O-F) in comparison with drugs treatment alone (T-MNX or O-F).Subjects and Methods: Fifty-eight subjects, 27 men and 31 women (mean age 38 years, range: 19-61 years) with AGA (Grade III-IV-V of Norwood-Hamilton scale) or FAGA (Ludwig Grade I/II) participated in the trial, after their written informed consent.The subjects were randomized to one of the following four treatment groups: Group1: GFM-DA+T-MNX (n=17); Group 2: GFM-DA-O-F (n= 15); Group 3: T-MNX alone (n=14) and Group4: O-F alone (n=12).For female subjects randomization to F groups was allowed only for menopausal women.The primary endpoint was the evolution of a 7-point Global Photographic Assessment score (GPAS; from -3 to +3) from baseline to week 24, evaluated in a blinded fashion.GPAS was evaluated also at week 12. Secondary endpoints were: 1)the comparison of GPAS scores at week 24 in all GFM-DA