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

July 24, 2012 updated by: Kasiak Research Pvt. Ltd.

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Thane, Maharashtra, India, 400610
        • Kasiak Research Pvt Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Calibre & Density of Hair as assessed by Folliscope
Time Frame: Day 0, Month 4, End of study - Month 6
Day 0, Month 4, End of study - Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Photographic Assessment
Time Frame: Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6
Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6

Other Outcome Measures

Outcome Measure
Time Frame
Physician's Assessment Score
Time Frame: End of study - Month 6
End of study - Month 6
Patient's Assessment Score
Time Frame: End of study - Month 6
End of study - Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasiak Research Pvt. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

October 1, 2012

Study Completion (ANTICIPATED)

November 1, 2012

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (ESTIMATE)

July 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRPL/HPL-AGA/11-12/001A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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