Clinical Efficacy, Cosmetic Acceptability, and Local Tolerability of a New Formulation of Topical 5% Minoxidil without Propylene glycol
Minoxidil (Mnx) is a topical drug indicated for the treatment of androgenic alopecia and female androgenic alopecia (AGA/ FAGA) both in men and women. Mnx can counteract the sex hormone-dependent miniaturization process of hair follicle which characterizes AGA physiopathology. The Mnx molecule could exert a vasodilation effect with a consequent positive action on the microcirculation of the scalp but at the same time favouring the cell cycle and cell proliferation, favouring at the hair follicle the anagen phase. The clinical efficacy of Mnx in AGA is maintained only if the treatment is continued. Therefore, long-term tolerability and safety are crucial aspects of AGA therapy with topical Mnx. Mnx 5% and 2% lotions commonly contain propylene glycol (PG), a solvent component able to enhance Mnx water solubility. PG is also a penetration enhancer of Mnx molecule, therefore contributing to the clinical efficacy. PG could have, especially in the long-term, a negative effect on the skin barrier function. Several adverse reactions due to PG have been documented, like allergic contact dermatitis (6% of treated subjects), scalp dryness, irritation, burning and redness in subjects treated with classical PG-containing Mnx lotions. The latter can be observed in up to 30% of Mnx-treated patients. Rossi et al. in a recent review have reported that scalp pruritus and scaling are the most common side effects of Mnx lotions treatments. 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 (n=30) of patients. The aim of this study was to evaluate the clinical efficacy, cosmetic acceptability, and local tolerability of the 6-month application of this new PG-Free Mnx lotion in a real-life situation in a large sample of subjects.
Study design: The NOMINAL (NO-PG MINoxidil reAL life study) trial was a prospective multi centre open trial with an assessor-blinded efficacy evaluation, performed between January 2020 and February 2021, in 22 out-patients dermatology clinics which have enrolled, after their written informed consent, a total of 196 subjects of both sexes (106 men and 90 women, mean ± SD age 41 ± 15) with a diagnosis of mild to moderate AGA/FAGA.
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Journal of Clinical & Experimental Dermatology Research