The Efficacy and Safety of AP-FHG0604T on Female Pattern Hair Loss: A Randomized Double-blind Placebo-controlled Clinical Trial

Shin, Hyo Seung; Lee, Seung Ho; Kim, Dong Hyun; An, Jee Soo; Kwon, Oh Sang; Eun, Hee Chul; Kim, Kyu Han

Abstract

BACKGROUND: Hair loss is a very common disorder and the number of patients is known to be increasing. Female pattern hair loss (FPHL) is not only a medical problem but also a very severe psychosocial problem for many female patients. Anti-androgen drugs, mineral supplements and topical minoxidil have all been used for the treatment of FPHL. However they do not always achieve successful results and there is still much need for more effective therapy.
OBJECTIVE
The purpose of this 18-week, double-blind, placebo-controlled, randomized clinical trial was to investigate the efficacy and safety of a new topical agent, AP-FHG0604T, in the treatment of FPHL.
METHODS
A total of 33 women with FPHL (mean age: 33.4 years old) applied either a topical AP-FHG0604T solution (n=17), or placebo (vehicle for AP-FHG0604T solution; n=16) twice daily. Efficacy was evaluated by phototrichogram, investigator's photographic and patient's subjective assessments. All adverse effects were reported during the study.
RESULTS
After 18 weeks of therapy, topical AP-FHG0604T treatment showed a significant improvement compared to baseline values of total hair count, non-vellus hair count, and linear hair growth rate. In the placebo group, non-vellus hair count and ratio of anagen hair significantly decreased. The change rates of total hair count and non-vellus hair count in the AP-FHG0604T group were significantly higher than those in the placebo group. Neither investigator's photographic assessments nor patient's subjective assessments of hair growth showed statistically significant differences between the AP-FHG0604T group or the placebo group. Some patients who used AP- FHG0604T complained of local irritation during the study, but the irritation was so mild that they did not need any treatment for this.
CONCLUSION
We conclude that AP-FHG0604T is a safe and efficient topical agent which can be used as another treatment of choice for FPHL, as shown by objective assessment with phototrichogram.