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

NCT01644422 | Unknown Phase 1 DMC

• 1 other identifier: KRPL/HPL-AGA/11-12/001B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• Improvement in Calibre & Density of Hair as assessed by Folliscope

  Day 0, Month 2, End of Study - Month 4

Secondary Outcomes (1)

• Photographic assessment

  Day 0, Month 1, Month 2, Month 3, End of Study - Month 4

Other Outcomes (2)

• Physician's assessment score

  End of Study - Month 4

• Patient's self assessment score

  End of Study - Month 4

Study Arms (3)

Study arm A

OTHER

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

Biological: Autologous Human Platelet Lysate

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

Biological: Autologous Human Platelet Lysate

Control arm C

OTHER

Subject will receive Standard hair follicle transplant

Other: Standard hair follicle transplant

Interventions

Autologous Human Platelet Lysate BIOLOGICAL

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

Study arm A

Standard hair follicle transplant OTHER

Control arm subject will receive Standard hair follicle transplant

Control arm C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasiak Research Pvt. Ltd.: lead

Study Sites (1)

Kasiak Research Pvt Ltd

Thane, Maharashtra, 400610, India

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Rajendarsingh Rajput, Dr.

  Dr. Rajesh Rajput Hair Restore

  PRINCIPAL INVESTIGATOR

• Sandeep Sattur, Dr.

  Hairrevive

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 25, 2012

Record last verified: 2012-07

Locations

IN (1)