A Study to Determine Safety & Efficacy of Autologous Huma... | NCT01644461

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

NCT01644461

Sponsor

Kasiak Research Pvt. Ltd.

Status

Unknown status

Last Update Posted

Jul 25, 2012Estimated

Enrollment

20Estimated

Phase

Phase 1Phase 2

Conditions

Facial Wrinkles (Nasolabial Folds)

Interventions

Autologous Human Platelet Lysate

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Oct 2012Estimated

Completion Date

Nov 2012Estimated

First Submitted Date

Jul 17, 2012

First Submission Date that Met QC Criteria

Jul 17, 2012

First Posted Date

Jul 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2012

Last Update Posted Date

Jul 25, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group	Other	All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region	Other: Autologous Human Platelet Lysate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous Human Platelet Lysate	Other	All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region	Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile		Day 0, End of Study - 3 months

Secondary Outcomes

Measure	Description	Time Frame
Global Aesthetic Improvement Scale		Day 0, End of study - Month 3

Other Outcomes

Measure	Description	Time Frame
Photographic assessments		Day 0, Month 1, Month 2, End of study - Month 3
Physician's assessment scores		End of Study - 3 months
Patient's assessment scores

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachita Dhurat, Dr.	Dr Rachita's Skin, Trichology & Aesthetic Centre	Principal Investigator
Geetanjali Shetty, Dr.	Kapadia Multispeciality Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasiak Research Pvt Ltd		Thane	Maharashtra	400610	India