Evaluation of the safety and effectiveness of intradermal administration of QR678 Neo ® hair growth factor formulation: A phase-IV, open-label, single-arm multi-ethnicity clinical trial.

BACKGROUND: Intradermal administration of QR678 Neo ® hair re-growth factor formulation has already proven its effectiveness and safety in treating androgenetic alopecia and female pattern hair loss. AIM: This study aims to evaluate effectiveness and safety of hair re-growth factor formulation at multiple centers for reduction of hair fall and regrowth of hair in androgenetic alopecia and female pattern hair loss. MATERIALS AND METHODS: An open-label, prospective, and interventional study was carried out at multiple centers of different countries. A total of 2428 patients with androgenetic alopecia and female pattern hair loss within the age range of 18-65 years were included in the study. Hair pull test, global photographic assessment, videomicroscopic assessment tests were performed at the beginning, after fourth and eighth sessions, and self-assessment through questionnaire related to satisfaction and side effects was carried out at beginning and at after eight session. RESULTS: Hair pull test was positive in only 12% of the patients after eight sessions. Beneficial results were noted in the global assessment score (mean-6) after fourth session and eighth session (mean-8). Huge improvement was noted in terminal hair count, vellus hair count, and hair density after eighth sessions. Also, with self-assessment score, a higher satisfaction score was noted. On long-term follow-up as well, no side effects were noted. CONCLUSION: Intradermal administration of QR678 Neo ® is an innovative, efficacious, and safe technique for the treatment of androgenetic alopecia and female pattern hair loss.