NCT01644461

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 25, 2012

Status Verified

July 1, 2012

Enrollment Period

6 months

First QC Date

July 17, 2012

Last Update Submit

July 24, 2012

Conditions

Facial Wrinkles (Nasolabial Folds)

Outcome Measures

Primary Outcomes (1)

  • Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile

    Day 0, End of Study - 3 months

Secondary Outcomes (1)

  • Global Aesthetic Improvement Scale

    Day 0, End of study - Month 3

Other Outcomes (3)

  • 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

    End of Study - 3 months

Study Arms (1)

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

Autologous Human Platelet LysateOTHER

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

Study Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasiak Research Pvt Ltd

Thane, Maharashtra, 400610, India

Location

Study Officials

  • Rachita Dhurat, Dr.

    Dr Rachita's Skin, Trichology & Aesthetic Centre

    PRINCIPAL INVESTIGATOR

  • Geetanjali Shetty, Dr.

    Kapadia Multispeciality Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

July 25, 2012

Record last verified: 2012-07

Locations

IN(1)