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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 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

July 12, 2012
July 24, 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 ] [ Designated as safety issue: No ]
Incidence of all adverse events will be noted [ Time Frame: Randomisation upto End of Study at 6 Months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
  • 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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Name: Autologous Human Platelet Lysate (HPL)
  • 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
  • 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.
 
Active, not recruiting
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.
Male
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01643629
KRPL/HPL-AGA/11-12/001A
Yes
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