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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Kasiak Research Pvt. Ltd..
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hair Diseases
Hypotrichosis
Pathological Conditions, Anatomical
Skin Diseases
Finasteride
Minoxidil
5-alpha Reductase Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 21, 2014