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

Androgenetic Alopecia Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01643629
• Other study ID #: KRPL/HPL-AGA/11-12/001A
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: July 12, 2012
• Last updated: July 24, 2012
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: July 2012
• Source: Kasiak Research Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

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)

Locations

Country	Name	City	State
India	Kasiak Research Pvt Ltd	Thane	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Kasiak Research Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physician's Assessment Score		End of study - Month 6	No
Other	Patient's Assessment Score		End of study - Month 6	No
Primary	Change in Calibre & Density of Hair as assessed by Folliscope		Day 0, Month 4, End of study - Month 6	No
Secondary	Photographic Assessment		Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6	No