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Trial record 26 of 103 for:    "androgenetic alopecia" OR "female pattern baldness" OR "male pattern baldness"

Study To Determine Safety & Efficacy Of Autologous Human Platelet Lysate in Androgenetic Alopecia After Hair Transplant

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ClinicalTrials.gov Identifier: NCT01644422
Recruitment Status : Unknown
Verified July 2012 by Kasiak Research Pvt. Ltd..
Recruitment status was:  Active, not recruiting
First Posted : July 19, 2012
Last Update Posted : July 25, 2012
Sponsor:
Information provided by (Responsible Party):
Kasiak Research Pvt. Ltd.

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 undergoing hair transplantation. The study is being conducted at 2 centers in India. The primary endpoints are Increase in Hair Follicle viability after transplant, 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 or disease Intervention/treatment Phase
Androgenetic Alopecia Biological: Autologous Human Platelet Lysate Other: Standard hair follicle transplant Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 Safety & Efficacy Of Autologous Human Platelet Lysate For Treatment Of Androgenetic Alopecia In Patients Undergoing Hair Transplant
Study Start Date : January 2012
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Study arm A
Subjects will receive hair follicles transplants that are dipped in HPL before transplant
Biological: Autologous Human Platelet Lysate
Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant

Study arm B
Subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection one week after transplant
Biological: Autologous Human Platelet Lysate
Study arm B subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection

Control arm C
Subject will receive Standard hair follicle transplant
Other: Standard hair follicle transplant
Control arm subject will receive Standard hair follicle transplant




Primary Outcome Measures :
  1. Improvement in Calibre & Density of Hair as assessed by Folliscope [ Time Frame: Day 0, Month 2, End of Study - Month 4 ]

Secondary Outcome Measures :
  1. Photographic assessment [ Time Frame: Day 0, Month 1, Month 2, Month 3, End of Study - Month 4 ]

Other Outcome Measures:
  1. Physician's assessment score [ Time Frame: End of Study - Month 4 ]
  2. Patient's self assessment score [ Time Frame: End of Study - Month 4 ]


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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 unwilling to or unable to comply with the study protocol.
  • Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or participating in another trial in the past 30 days.

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): NCT01644422


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

Responsible Party: Kasiak Research Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01644422     History of Changes
Other Study ID Numbers: KRPL/HPL-AGA/11-12/001B
First Posted: July 19, 2012    Key Record Dates
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