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

NCT ID: NCT01644422

Last Updated: 2012-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study arm A

Subjects will receive hair follicles transplants that are dipped in HPL before transplant

Group Type OTHER

Autologous Human Platelet Lysate

Intervention Type BIOLOGICAL

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

Group Type OTHER

Autologous Human Platelet Lysate

Intervention Type BIOLOGICAL

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

Group Type OTHER

Standard hair follicle transplant

Intervention Type OTHER

Control arm subject will receive Standard hair follicle transplant

Interventions

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Autologous Human Platelet Lysate

Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant

Intervention Type 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

Intervention Type BIOLOGICAL

Standard hair follicle transplant

Control arm subject will receive Standard hair follicle transplant

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Kasiak Research Pvt. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rajendarsingh Rajput, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dr. Rajesh Rajput Hair Restore

Sandeep Sattur, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hairrevive

Locations

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Kasiak Research Pvt Ltd

Thāne, Maharashtra, India

Site Status

Countries

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India

Other Identifiers

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KRPL/HPL-AGA/11-12/001B

Identifier Type: -

Identifier Source: org_study_id