RESUMO
AIM: A multi - centre two years the long prospective open clinical study was conducted in five countries located in four different continents from May 2015 to evaluate the clinical safety and efficacy of Automatic Biofibre hair implant in male and female androgenetic alopecia. Biofibre®is a CE/TGA certified medical grade polyamide fibre suitable for implantation. MATERIAL AND METHODS: A total of 213 patients were enrolled in the study. Patients were assessed pre -operatively by Hamilton scale grading and the percentage of scalp covered by hair. All the patients underwent Biofibre hair implantation by a standardised surgical technique followed by adequate post-operative care. Efficacy of the implant was evaluated by surgeons and patients bimonthly for the first year and trimonthly during the second year. Any adverse effects were recorded during these visits. RESULTS: At the completion of the study period, a total of 194 patients concluded the trial and the results were statistically evaluated. Both Hamilton scale grading and covered area percent improved at the end of the study, and subjective and objective evaluations revealed satisfactory results. Side effects were reported in only 18 cases (9.27%) which were easily controlled by either topical or systemic treatment in 8 to 10 days. CONCLUSION: Overall a successful result was noticed in 97.94% of patients with great psychological satisfaction.