Title

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
  • Phase

    Phase 1/Phase 2
  • Study Type

    Interventional
  • Status

    Unknown status
  • Intervention/Treatment

    autologous human platelet lysate ...
  • Study Participants

    30
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 Started
Jan 31
2012
Primary Completion
Oct 31
2012
Anticipated
Study Completion
Nov 30
2012
Anticipated
Last Update
Jul 25
2012
Estimate

Biological Autologous Human Platelet Lysate

Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant

Biological Autologous Human Platelet Lysate

Study arm B subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection

Other Standard hair follicle transplant

Control arm subject will receive Standard hair follicle transplant

Study arm A Other

Subjects will receive hair follicles transplants that are dipped in HPL before transplant

Study arm B Other

Subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection one week after transplant

Control arm C Other

Subject will receive Standard hair follicle transplant

Criteria

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.
No Results Posted