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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.
July 12, 2012
July 18, 2012
July 25, 2012
January 2012
October 2012   (Final data collection date for primary outcome measure)
Change in Calibre & Density of Hair as assessed by Folliscope [ Time Frame: Day 0, Month 4, End of study - Month 6 ]
Incidence of all adverse events will be noted [ Time Frame: Randomisation upto End of Study at 6 Months ]
Complete list of historical versions of study NCT01643629 on ClinicalTrials.gov Archive Site
Photographic Assessment [ Time Frame: Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6 ]
- Improvement in Calibre & Density of Hair as assessed by Folliscope - Photographic assessment - Physician's assessment score - Patient's self assessment score [ Time Frame: Randomisation, at 4 Months and at End of study at 6 Months ]
  • Physician's Assessment Score [ Time Frame: End of study - Month 6 ]
  • Patient's Assessment Score [ Time Frame: End of study - Month 6 ]
Not Provided
 
A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Androgenetic Alopecia
  • 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: 2 % Minoxidil and /or Finasteride
    Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride)
  • Study arm A
    Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.
    Intervention: Biological: Autologous Human Platelet Lysate (HPL)
  • Control Arm B
    Control arm B will include subjects receiving Standard therapy
    Intervention: Other: 2 % Minoxidil and /or Finasteride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
November 2012
October 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01643629
KRPL/HPL-AGA/11-12/001A
Yes
Not Provided
Not Provided
Kasiak Research Pvt. Ltd.
Kasiak Research Pvt. Ltd.
Not Provided
Principal Investigator: Rajendarsingh Rajput, Dr. Dr. Rajesh Rajput Hair Restore
Principal Investigator: Sandeep Sattur, Dr. Hairrevive
Kasiak Research Pvt. Ltd.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP