Efficacy and tolerability of HDMHG0401-10 in Patients with Androgenetic Alopecia-A Randomized Double-blind Placebo-controlled Trial

안드로겐 탈모증 환자에서 HDMHG0401-10의 탈모방지, 양모 효과 및 안전성 평가를 위한 임상시험

Background : Androgenetic alopecia (AGA) is an androgen-dependent hereditary disorder. Compared to the past, a rising number of patients with AGA have been seeking treatment. Oral finasteride and topical minoxidil are the only drugs approved, till now, by the Food and Drug Administration of USA for the treatment of this condition. Unfortunately, these treatment options are not satisfactory. Therefore, it has been necessary to develop new drugs for this psychologically frustrating disease. Methods : This is a 24-week, double-blinded, placebo-controlled, randomized clinical trial to determine whether a new topical treatment, HDMHG0401-10, is effective in showing clinical improvements in patients with AGA. A total of 41 men (23-49 years old) with AGA were treated either with the topical HDMHG0401-10 solution or a placebo, twice daily. Efficacy was evaluated by phototrichogram as well as patients' subjective and investigator's photographic assessments for change in hair density. Results : After 24 weeks of therapy, topical HDMHG0401-10 treatment resulted in significant improvement from the baseline in total hair count and showed to be significantly superior to the placebo in terms of hair loss count. There was no statistically significant difference in patients' and investigator's hair growth ratings between the HDMHG0401-l0 treated and placebo groups. HDMHG0401-l0 was generally well tolerated. Conclusion : We have confirmed the efficacy of HDMHG0401-10 in treating AGA in men, by an objective assessment with phototrichogram. No evidence of major side effects was seen.