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

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 Overview

• Status: Unknown
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Biological: Autologous Human Platelet Lysate; Biological: Autologous Human Platelet Lysate; Other: Standard hair follicle transplant

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Thane, Maharashtra, India, 400610
      • Kasiak Research Pvt Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study arm A; Subjects will receive hair follicles transplants that are dipped in HPL before transplant	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: Study arm B; Subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection one week after transplant	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: Control arm C; Subject will receive Standard hair follicle transplant	Other: Standard hair follicle transplant; Control arm subject will receive Standard hair follicle transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in Calibre & Density of Hair as assessed by Folliscope	Day 0, Month 2, End of Study - Month 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Photographic assessment	Day 0, Month 1, Month 2, Month 3, End of Study - Month 4

Other Outcome Measures

Outcome Measure	Time Frame
Physician's assessment score	End of Study - Month 4
Patient's self assessment score	End of Study - Month 4

Collaborators and Investigators

• Sponsor: Kasiak Research Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): November 1, 2012

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (Estimate): July 19, 2012

Study Record Updates

• Last Update Posted (Estimate): July 25, 2012
• Last Update Submitted That Met QC Criteria: July 24, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: KRPL/HPL-AGA/11-12/001B