Study To Determine Safety & Efficacy Of Autologous Human Platelet Lysate in Androgenetic Alopecia After Hair Transplant
A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate Safety & Efficacy Of Autologous Human Platelet Lysate For Treatment Of Androgenetic Alopecia In Patients Undergoing Hair Transplant
PhasePhase 1/Phase 2
Lead SponsorBharat Biotech International Limited
Intervention/Treatmentautologous human platelet lysate ...
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia undergoing hair transplantation. The study is being conducted at 2 centers in India. The primary endpoints are Increase in Hair Follicle viability after transplant, Improvement in Caliber & Density of hair and Improvement in Photographic assessment from randomization to end of study. The secondary endpoints are Physicians and Patients self assessment score.
Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant
Study arm B subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection
Control arm subject will receive Standard hair follicle transplant
Subjects will receive hair follicles transplants that are dipped in HPL before transplant
Subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection one week after transplant
Subject will receive Standard hair follicle transplant
Inclusion Criteria: Male subjects, aged between 18 to 50 years (both inclusive) and in general good health Subjects willing to refrain from other AGA treatments during the entire study duration Subjects who are willing to give informed consent and adhere to the study protocol Exclusion Criteria: Subjects aged <18 or > 50 years Subjects with dermatological disorder of scalp that might interfere with study evaluation Subjects on Anti-coagulant therapy Subjects with clinically significant medical or psychiatric disease as determined by the investigator. Subjects unwilling to or unable to comply with the study protocol. Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or participating in another trial in the past 30 days.