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A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Facial Wrinkles(Nasolabial Folds)

NCT ID: NCT01644461

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

2012-04-30

Study Completion Date

2012-11-30

Brief Summary

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This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile and Global Aesthetic Improvement Scale (GAIS). The secondary endpoints are improvement in photographic assessment, Physician's assessment scores, Patient's assessment scores form enrollment to end of study.

Detailed Description

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Conditions

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Facial Wrinkles (Nasolabial Folds)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Group

All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region

Group Type OTHER

Autologous Human Platelet Lysate

Intervention Type OTHER

All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region

Interventions

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Autologous Human Platelet Lysate

All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects (male and female), aged 18 to 40 years (both inclusive).
* Subjects willing to refrain from any other treatment for Nasolabial Folds.
* Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria

* Subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. Botox, Fillers etc
* Subjects with history of Connective tissue disease
* Subjects with autoimmune diseases
* 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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Rachita Dhurat, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dr Rachita's Skin, Trichology & Aesthetic Centre

Geetanjali Shetty, Dr.

Role: PRINCIPAL_INVESTIGATOR

Kapadia Multispeciality Hospital

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/11-12/002B

Identifier Type: -

Identifier Source: org_study_id