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Open Access Maced J Med Sci. 2017 Jan 20;6(1):38-42. doi: 10.3889/oamjms.2018.052. eCollection 2018 Jan 25.

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

Open access Macedonian journal of medical sciences

Amr Abdel-Hakim Rateb Said, Bogdan Morad Albzour, Mariangela Santiago, Manjul Agrawal, Miriam Rovesti, Francesca Satolli, Uwe Wollina, Georgi Tchernev, Jacopo Lotti, Torello Lotti

Affiliations

  1. University of Cairo, Egypt - Department of Dermatology, Cairo, Egypt.
  2. University Cluj-Napoca, Romania - Department of Dermatology, Romania.
  3. Hospital of Face Defects, Sao Paulo, Brazil - Department of Plastic Surgery, Sao Paulo, Brazil.
  4. Fortis Hospital, Shalimar Bagh, India.
  5. Department of Dermatology, University of Parma, Parma, Italy.
  6. Städtisches Klinikum Dresden, Department of Dermatology and Allergology, 01067 Dresden, Germany.
  7. Medical Institute of Ministry of Interior Department of General, Vascular and Abdominal Surgery, Sofia, Bulgaria.
  8. University G. Marconi of Rome - Dept. of Nuclear, Subnuclear and Radiation Physics, Rome, Italy.
  9. University G. Marconi of Rome, Dermatology and Venereology, Rome, Italy.

PMID: 29483977 PMCID: PMC5816310 DOI: 10.3889/oamjms.2018.052

Abstract

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.

Keywords: Alopecia; Baldness; Biofibre; Hair implant; Treatment

References

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