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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kasiak Research Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT01643629
First received: July 12, 2012
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Androgenetic Alopecia
 Biological: Autologous Human Platelet Lysate (HPL)
Other: 2 % Minoxidil and /or Finasteride
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kasiak Research Pvt. Ltd.:

Primary Outcome Measures:
  • Change in Calibre & Density of Hair as assessed by Folliscope [ Time Frame: Day 0, Month 4, End of study - Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Photographic Assessment [ Time Frame: Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Physician's Assessment Score [ Time Frame: End of study - Month 6 ] [ Designated as safety issue: No ]
  • Patient's Assessment Score [ Time Frame: End of study - Month 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study arm A
Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.
 Biological: Autologous Human Platelet Lysate (HPL)
Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.
Other Name: Autologous Human Platelet Lysate (HPL)
Control Arm B
Control arm B will include subjects receiving Standard therapy
 Other: 2 % Minoxidil and /or Finasteride
Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride)
Other Name: 2 % Minoxidil and /or Finasteride

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643629

Locations
India
Kasiak Research Pvt Ltd
Thane, Maharashtra, India, 400610
Sponsors and Collaborators
Kasiak Research Pvt. Ltd.
Investigators
Principal Investigator: Rajendarsingh Rajput, Dr. Dr. Rajesh Rajput Hair Restore
Principal Investigator: Sandeep Sattur, Dr. Hairrevive
  More Information

No publications provided

Responsible Party: Kasiak Research Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01643629     History of Changes
Other Study ID Numbers: KRPL/HPL-AGA/11-12/001A
Study First Received: July 12, 2012
Last Updated: July 24, 2012
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Finasteride
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013