Clinical updating study at 3 years on 278 patients treated by modern artificial hair implant technique (automatic biofibre®).

In this study, we report our multicentric experience of synthetic medical certified polyamide hair implants in male androgenetic, female menopausal, and chronic alopecia. Biofibre hair implantation was performed by means of a standardized, mini-invasive technique followed by regular postoperative care along 3 years. From May 2015, 278 patients were enrolled and 253 completed the trial; 202 men (79.9%) versus 51 women (20,1%). The average age was 43(± 4.29); 179 patients (70.1%) had taken previous treatments for alopecia. We evaluated efficacy (as judged by Hamilton scale grading, covered area percent, surgeon, and patient's subjective evaluation) and safety (as judged by adverse events). The overall scalp surface restored with artificial hair (mm2 spaced) and pre-postoperative general customers' satisfaction (by Hamilton scale grading) are reported, showing a significant (98,14%) subjective and objective improvement of the self-image. Twenty-two cases (8.75%) declared minor side effects generally counteracted by topical or short course systemic antibiotic and anti-inflammatory treatment. The average number of implanted fibers was 2,295 (SD 2.805; SE 200.9) ranging from 300 to 16,000. The average duration of pain and tenderness at the implant area was 2.2 days (SD 4.096; SE 0.2933) ranging from 1 to 20 days. A diagrammatic comparison of the Hamilton scale grading before and after the trial showed a dramatic improvement with the majority of the patients being in Hamilton grade II after implantation.

Automatic Artificial Hair Implant: Safety and Efficacy in Androgenetic Alopecia. A Prospective Study with a Highly Biocompatible Fiber.

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.