Study To Determine Safety & Efficacy Of Autologous Human Platelet Lysate in Androgenetic Alopecia After Hair Transplant

Kasiak Research

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Androgenetic Alopecia

Treatments: Biological: Autologous Human Platelet Lysate; Other: Standard hair follicle transplant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01644422

KRPL/HPL-AGA/11-12/001B

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Study arm A

Other group

Description:

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

Treatment:

Biological: Autologous Human Platelet Lysate

Biological: Autologous Human Platelet Lysate

Study arm B

Other group

Description:

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

Treatment:

Biological: Autologous Human Platelet Lysate

Biological: Autologous Human Platelet Lysate

Control arm C

Other group

Description:

Subject will receive Standard hair follicle transplant

Treatment:

Other: Standard hair follicle transplant