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A Pilot Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Acne Scarring

NCT ID: NCT01644435

Last Updated: 2012-10-15

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-10-31

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 Acne Scarring. The study is being conducted at 2 centers in India. The primary endpoint is change in the Global Acne scarring classification scores from screening to end of the study. The secondary endpoints are Photographic Assessment, Physicians assessment score and Patients self assessment score.

Detailed Description

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Conditions

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ACNE SCARRING

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study arm A

Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring

Group Type OTHER

Autologous Human Platelet Lysate

Intervention Type BIOLOGICAL

Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring

Study arm B

Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring.

Group Type OTHER

Autologous Human Platelet Lysate

Intervention Type BIOLOGICAL

Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring

Interventions

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Autologous Human Platelet Lysate

Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring

Intervention Type BIOLOGICAL

Autologous Human Platelet Lysate

Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects (male and female), aged 18 to 40 years (both inclusive).
* Subject willing to refrain from any other treatment of Acne Scarring during entire study duration.
* Non-pregnant, non-lactating females who agree to use adequate and acceptable methods of contraception from screening and throughout the course of the study.
* Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria

* Subjects with active infection or active acne.
* Subjects receiving treatment: NSAIDs treatment within the last 7 days prior to the study.
* Subjects with history of connective tissue disease.
* Subjects with metabolic or hematopoietic disorders.
* Subjects with known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia.
* Subjects who have received prior chemotherapy and radiotherapy
* 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 30days
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 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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Sharmila Patil, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dermocosmetic laser center hair and skin clinic

Pankaj Maniar, Dr.

Role: PRINCIPAL_INVESTIGATOR

Radiance Cosmetology Clinique

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-AS/11-12/004

Identifier Type: -

Identifier Source: org_study_id