Efficacy and tolerability assessment of a polynucleotide‐based gel for improvement of pattern hair loss Running title: A polynucleotide‐based gel for improvement of pattern hair loss

Abstract

Abstract Androgenetic alopecia (AGA) is the leading etiology for scalp hair loss in both genders. Apart from the limited approved pharmaceuticals, there are several suggested nonsurgical-nondrug therapies, including scalp injectables enriched with polynucleotides, however, limited data exists and is mostly limited to one gender. This study evaluates the efficacy and tolerability of a polynucleotide injectable gel quantitatively and quantitively for the treatment of AGA in both genders. Twenty patients with mild to moderate AGA were recruited. A prefilled gel containing 15 mg of polynucleotides was injected for 10 sessions over 4 months {4,2,2,2}. End goals were set at W6, W18, and W24. Evaluations included standard scalp photography scored based on the Global Photographic Review criteria, Likert hair improvement scales for both patient and dermatologist, trichogram, comb test, and adverse reaction. Trial registration number was, IRCT20150101020514N15. The mean age was 37.7 ± 8.1 years. Analysis showed 65%, 77.8%, and 63.2% of patients had slight or moderate improvement in hair growth at W6, W18, and W24, respectively. A statistically significant decrease in hair shedding was observed at all visits. A statically significant increase was observed in the terminal/ vellus hair ratio and the mean value of anagen/ telogen hair ratio at W18 and W24. A statistically significant increase in the mean thickness of hairs was observed at W24. At W6, W18, and W24, 85%, 50%, and 47.4% of participants reported “Improvement” for their hair, respectively. No life-threatening side effects were detected. Mild headache, mild swelling, and maculopapular rash were reported in 2, 2, and 2 patients respectively which were abated with outpatient treatment. This study demonstrated polynucleotide gel injection to be an effective treatment option for decreasing hair shedding and increasing the mean thickness of the hairs with high patient satisfaction and safety profile in male and female AGA.