Clinical Efficacy, Cosmetic Acceptability, and Local Tolerability of a New Formulation of Topical 5% Minoxidil without Propylene glycol: A 6-month, Multicentre, Real-life, Prospective, Assessor-Blinded Study in 196 Subjects with Hair Loss. The andldquo;NOMINALandrdquo; Trial

Abstract

Background and trial objectives: A new propylene glycol (PG)-free 5% minoxidil (PG-Free-Mnx) lotion has been recently commercialized. Clinical efficacy and local tolerability have been, so far, documented in a limited number of patients. The aim of this study was to evaluate the clinical efficacy, cosmetic acceptability, and local tolerability of 6-month application of this new PG-Free Mnx lotion in a real-life situation. Materials and methods: The NOMINAL (NO-PG MINoxidil reAL life study) trial was performed in 22 out-patients Italian dermatology clinics. A total of 196 subjects of both sexes with a diagnosis of AGA/FAGA were enrolled in the trial, after their written informed consent. PG-Free-Mnx lotion was applied 1 ml twice daily for 6 months. Clinical efficacy was evaluated in an open fashion in all the enrolled subjects with a 5-grade scale score (from-2: severe worsening, to +2: very good improvement in comparison with baseline condition). In a subgroup of subjects (n=60) an assessor-blinded clinical efficacy evaluation has been also performed using high definition standardized and coded scalp global pictures at baseline, and after 6 months by an assessor unaware of the temporal sequence using a 3-grade score (from 0: no improvement to 3: very high improvement). Cosmetic acceptability evaluation was assessed using a 7-item questionnaire using a 10-point scale score, with score 1meaning not at all and score 10 meaning the worst possible condition. Cosmetic acceptability and clinical efficacy were evaluated after 12 and 24 weeks of treatment. Global tolerability, assessed at week 24, was evaluated with a 4-grade scale score (from -1: very low tolerability to +2: very good tolerability). Results: All but seven (3.6%) subjects concluded the study. Clinical efficacy scores (open evaluation) were 0.8 ± 0.7 and 1.0 ± 0.7 at week 12 and 24, respectively. Good or very good clinical response (score +1 or +2) at week 12 and week 24 was observed in 64% and 74% respectively of the subjects with a similar response in women (75%) and men (73%). Baseline severity of AGA/FAGA was inversely correlated with the clinical response with a better outcome in subjects with AGA type II in comparison with subjects with types III/ IV AGA. The clinical efficacy was confirmed by the assessor-blinded evaluation of the subgroup of 60 subjects’ pictures at baseline (clinical score at baseline: 0.2 ± 0.4 vs. 1.8 ± 0.7 after 6 months; p=0.0001; absolute mean difference: 1.6; 95% CI: 1.1 to 2.0). Cosmetic acceptability score mean values were always 7) burning, itching or redness sensations. Conclusion: This new PG-free lotion shows, in real-life conditions, a very good cosmetic acceptability and tolerability profile. Clinical efficacy, evaluated both in open and assessor-blinded fashions, was also documented, and it was in line with the available data of traditional Mnx formulations with propylene glycol.