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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01644422
Other study ID # KRPL/HPL-AGA/11-12/001B
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received July 17, 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
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 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Biological:
Autologous Human Platelet Lysate
Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant
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
Other:
Standard hair follicle transplant
Control arm subject will receive Standard hair follicle transplant

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 4 No
Other Patient's self assessment score End of Study - Month 4 No
Primary Improvement in Calibre & Density of Hair as assessed by Folliscope Day 0, Month 2, End of Study - Month 4 No
Secondary Photographic assessment Day 0, Month 1, Month 2, Month 3, End of Study - Month 4 No
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