A Study to Determine the Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Dark Circles

NCT ID: NCT01644448

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

2012-03-31

Study Completion Date

2012-11-30

Brief Summary

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This is a multicentre, open label, randomized, pilot study to evalute safety and efficacy of Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self assessment score. The secondary endpoints are improvement in photographic assessment form randomization to end of study.

Detailed Description

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Conditions

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Periorbital Hyperpigmentation (Dark Circles)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Study arm A

Subjects will receive one dose of 5 ml of Autologous Human Platelet Lysate with simultaneous micro-needling on day 2

Group Type OTHER

Autologous Human Platelet Lysate

Intervention Type OTHER

Subjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2

Control Arm B

Topical Applications of the standard therapy as directed by the investigator

Group Type OTHER

Standard Therapy

Intervention Type OTHER

Topical Applications as directed by the investigator

Interventions

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Autologous Human Platelet Lysate

Subjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2

Intervention Type OTHER

Standard Therapy

Topical Applications as directed by the investigator

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects (male and female), aged 18 to 55 years (both inclusive) with Periorbital Hyperpigmentation.
* Subject willing to refrain from any other treatment of Periorbital Hyperpigmentation during entire study duration.
* Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria

* Subjects aged less than 18 and more than 55 years
* Subjects with history of connective tissue disease.
* Subjects with metabolic or hematopoietic disorders
* Subjects unwilling to or unable to comply with the study protocol.
* Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30 days.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

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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Farida Modi, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dermacare

Preeti Savardekar, Dr.

Role: PRINCIPAL_INVESTIGATOR

Shree Krishna Polyclinic

Sharmila Patil, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dr. Sharmila's Dermocosmetic laser center, hair and skin clinic

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-FR/11-12/002A

Identifier Type: -

Identifier Source: org_study_id