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

Primary Purpose

Androgenetic Alopecia

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Autologous Human Platelet Lysate
Autologous Human Platelet Lysate
Standard hair follicle transplant
Sponsored by
Kasiak Research Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept 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.

Sites / Locations

  • Kasiak Research Pvt Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Study arm A

Study arm B

Control arm C

Arm Description

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

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

Subject will receive Standard hair follicle transplant

Outcomes

Primary Outcome Measures

Improvement in Calibre & Density of Hair as assessed by Folliscope

Secondary Outcome Measures

Photographic assessment

Full Information

First Posted
July 17, 2012
Last Updated
July 24, 2012
Sponsor
Kasiak Research Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01644422
Brief Title
Study To Determine Safety & Efficacy Of Autologous Human Platelet Lysate in Androgenetic Alopecia After Hair Transplant
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kasiak Research Pvt. Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study arm A
Arm Type
Other
Arm Description
Subjects will receive hair follicles transplants that are dipped in HPL before transplant
Arm Title
Study arm B
Arm Type
Other
Arm Description
Subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection one week after transplant
Arm Title
Control arm C
Arm Type
Other
Arm Description
Subject will receive Standard hair follicle transplant
Intervention Type
Biological
Intervention Name(s)
Autologous Human Platelet Lysate
Intervention Description
Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant
Intervention Type
Biological
Intervention Name(s)
Autologous Human Platelet Lysate
Intervention Description
Study arm B subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection
Intervention Type
Other
Intervention Name(s)
Standard hair follicle transplant
Intervention Description
Control arm subject will receive Standard hair follicle transplant
Primary Outcome Measure Information:
Title
Improvement in Calibre & Density of Hair as assessed by Folliscope
Time Frame
Day 0, Month 2, End of Study - Month 4
Secondary Outcome Measure Information:
Title
Photographic assessment
Time Frame
Day 0, Month 1, Month 2, Month 3, End of Study - Month 4
Other Pre-specified Outcome Measures:
Title
Physician's assessment score
Time Frame
End of Study - Month 4
Title
Patient's self assessment score
Time Frame
End of Study - Month 4

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajendarsingh Rajput, Dr.
Organizational Affiliation
Dr. Rajesh Rajput Hair Restore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandeep Sattur, Dr.
Organizational Affiliation
Hairrevive
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasiak Research Pvt Ltd
City
Thane
State/Province
Maharashtra
ZIP/Postal Code
400610
Country
India

12. IPD Sharing Statement

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

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