NCT02396290

Brief Summary

Investigation of Clinical Effect of Platelet Rich Plasma Combined With Laser on Acne Scar

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
Last Updated

March 24, 2015

Status Verified

July 1, 2013

Enrollment Period

6 months

First QC Date

March 9, 2015

Last Update Submit

March 17, 2015

Conditions

Acne Scar

Keywords

acne scarfractional carbon dioxide laserplatelet rich plasma

Outcome Measures

Primary Outcomes (1)

  • Global assessment of acne scar

    5-point grading of acne scar

    12 weeks

Secondary Outcomes (2)

  • ECCA (échelle d'évaluation clinique des cicatrices d'acné)

    12 weeks

  • adverse effect assessment

    12 weeks

Study Arms (2)

fractional CO2 laser with PRP

EXPERIMENTAL

fractional carbon dioxide laser followed by intradermal injection of platelet rich plasma

Procedure: fractional carbon dioxide laser with platelet rich plasma

fractional CO2 laser with NS

ACTIVE COMPARATOR

fractional carbon dioxide laser followed by intradermal injection of NS

Procedure: fractional carbon dioxide laser with NS

Interventions

fractional carbon dioxide laser with platelet rich plasmaPROCEDURE

fractional carbon dioxide laser followed by platelet rich plasma injection

Also known as: COFRAX with autologous PRP
fractional CO2 laser with PRP
fractional carbon dioxide laser with NSPROCEDURE

fractional carbon dioxide laser followed by normal saline injection

Also known as: COFRAX with normal saline
fractional CO2 laser with NS

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • moderate to severe acne scar

You may not qualify if:

  • taken procedures for acne scar within 6 months
  • underlying diabetes mellitus, keloid, or malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Seoul National University College of Medicine

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Tierney EP, Eisen RF, Hanke CW. Fractionated CO2 laser skin rejuvenation. Dermatol Ther. 2011 Jan-Feb;24(1):41-53. doi: 10.1111/j.1529-8019.2010.01377.x.

    PMID: 21276157BACKGROUND

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Dae Hun Suh, PhD

    Department of Dermatology, Seoul National University College of Medicine

    STUDY CHAIR

  • Seonguk Min, Msc

    Department of Dermatology, Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 24, 2015

Study Start

March 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 24, 2015

Record last verified: 2013-07

Locations

KR(1)