Trial | NCT01643629  Report issue

Title

A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia
A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment Of Androgenetic Alopecia (AGA)

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia. The study is being conducted at 2 centers in India. The primary endpoints are 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 (HPL)

Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.

Other 2 % Minoxidil and /or Finasteride

Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride)

Study arm A Other

Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.

Control Arm B Other

Control arm B will include subjects receiving Standard therapy

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 with dermatological disorder of scalp that might interfere with study evaluation
Subjects unwilling to or unable to comply with the study protocol.
No Results Posted