A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia

Kasiak Research

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Androgenetic Alopecia

Treatments: Biological: Autologous Human Platelet Lysate (HPL); Other: 2 % Minoxidil and /or Finasteride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01643629

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

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. 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.

Enrollment: 20 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 with dermatological disorder of scalp that might interfere with study evaluation
• Subjects unwilling to or unable to comply with the study protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Study arm A

Other group

Description:

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

Treatment:

Biological: Autologous Human Platelet Lysate (HPL)

Control Arm B

Other group

Description:

Control arm B will include subjects receiving Standard therapy

Treatment:

Other: 2 % Minoxidil and /or Finasteride