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

NCT ID: NCT01643629

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

20 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. 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.

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

Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.

Group Type OTHER

Autologous Human Platelet Lysate (HPL)

Intervention Type BIOLOGICAL

Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.

Control Arm B

Control arm B will include subjects receiving Standard therapy

Group Type OTHER

2 % Minoxidil and /or Finasteride

Intervention Type OTHER

Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride)

Interventions

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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.

Intervention Type BIOLOGICAL

2 % Minoxidil and /or Finasteride

Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride)

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 with dermatological disorder of scalp that might interfere with study evaluation
* Subjects unwilling to or unable to comply with the study protocol.
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/11-12/001A

Identifier Type: -

Identifier Source: org_study_id