We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Kasiak Research Pvt. Ltd..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01643629
First Posted: July 18, 2012
Last Update Posted: July 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kasiak Research Pvt. Ltd.
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Photographic Assessment [ Time Frame: Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6 ]

Other Outcome Measures:
  • Physician's Assessment Score [ Time Frame: End of study - Month 6 ]
  • Patient's Assessment Score [ Time Frame: End of study - Month 6 ]

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.
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)

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kasiak Research Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01643629     History of Changes
Other Study ID Numbers: KRPL/HPL-AGA/11-12/001A
First Submitted: July 12, 2012
First Posted: July 18, 2012
Last Update Posted: July 25, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Finasteride
Minoxidil
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents
Antihypertensive Agents
Vasodilator Agents