Back to resultsA Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia
Primary Purpose
Androgenetic Alopecia
Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Autologous Human Platelet Lysate (HPL)
2 % Minoxidil and /or Finasteride
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia
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 with dermatological disorder of scalp that might interfere with study evaluation
- Subjects unwilling to or unable to comply with the study protocol.
Sites / Locations
- Kasiak Research Pvt Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Study arm A
Control Arm B
Arm Description
Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.
Control arm B will include subjects receiving Standard therapy
Outcomes
Primary Outcome Measures
Change in Calibre & Density of Hair as assessed by Folliscope
Secondary Outcome Measures
Photographic Assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01643629
Brief Title
A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia
Official Title
A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment Of Androgenetic Alopecia (AGA)
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. 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.
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
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study arm A
Arm Type
Other
Arm Description
Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.
Arm Title
Control Arm B
Arm Type
Other
Arm Description
Control arm B will include subjects receiving Standard therapy
Intervention Type
Biological
Intervention Name(s)
Autologous Human Platelet Lysate (HPL)
Intervention Description
Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.
Intervention Type
Other
Intervention Name(s)
2 % Minoxidil and /or Finasteride
Intervention Description
Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride)
Primary Outcome Measure Information:
Title
Change in Calibre & Density of Hair as assessed by Folliscope
Time Frame
Day 0, Month 4, End of study - Month 6
Secondary Outcome Measure Information:
Title
Photographic Assessment
Time Frame
Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6
Other Pre-specified Outcome Measures:
Title
Physician's Assessment Score
Time Frame
End of study - Month 6
Title
Patient's Assessment Score
Time Frame
End of study - Month 6
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 with dermatological disorder of scalp that might interfere with study evaluation
Subjects unwilling to or unable to comply with the study protocol.
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
Learn more about this trial
A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia
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