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Clinical Effect of Platelet Rich Plasma Combined With Laser on Scar

Primary Purpose

Acne Scar

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fractional carbon dioxide laser with platelet rich plasma
fractional carbon dioxide laser with NS
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scar focused on measuring acne scar, fractional carbon dioxide laser, platelet rich plasma

Eligibility Criteria

19 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • moderate to severe acne scar

Exclusion Criteria:

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

Sites / Locations

  • Department of Dermatology, Seoul National University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fractional CO2 laser with PRP

fractional CO2 laser with NS

Arm Description

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

fractional carbon dioxide laser followed by intradermal injection of NS

Outcomes

Primary Outcome Measures

Global assessment of acne scar
5-point grading of acne scar

Secondary Outcome Measures

ECCA (échelle d'évaluation clinique des cicatrices d'acné)
quantitative analysis of acne scar
adverse effect assessment
adverse effect assessment - erythema index, Epithelization Scale (0-12 point)

Full Information

First Posted
March 9, 2015
Last Updated
March 17, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02396290
Brief Title
Clinical Effect of Platelet Rich Plasma Combined With Laser on Scar
Official Title
Clinical Study on Efficacy and Safety of Platelet Rich Plasma Combined With Laser for Scar Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigation of Clinical Effect of Platelet Rich Plasma Combined With Laser on Acne Scar
Detailed Description
Platelet Rich Plasma may relieve the adverse effect of laser treatment. and it can be expected to improve acne treatment result.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scar
Keywords
acne scar, fractional carbon dioxide laser, platelet rich plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fractional CO2 laser with PRP
Arm Type
Experimental
Arm Description
fractional carbon dioxide laser followed by intradermal injection of platelet rich plasma
Arm Title
fractional CO2 laser with NS
Arm Type
Active Comparator
Arm Description
fractional carbon dioxide laser followed by intradermal injection of NS
Intervention Type
Procedure
Intervention Name(s)
fractional carbon dioxide laser with platelet rich plasma
Other Intervention Name(s)
COFRAX with autologous PRP
Intervention Description
fractional carbon dioxide laser followed by platelet rich plasma injection
Intervention Type
Procedure
Intervention Name(s)
fractional carbon dioxide laser with NS
Other Intervention Name(s)
COFRAX with normal saline
Intervention Description
fractional carbon dioxide laser followed by normal saline injection
Primary Outcome Measure Information:
Title
Global assessment of acne scar
Description
5-point grading of acne scar
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
ECCA (échelle d'évaluation clinique des cicatrices d'acné)
Description
quantitative analysis of acne scar
Time Frame
12 weeks
Title
adverse effect assessment
Description
adverse effect assessment - erythema index, Epithelization Scale (0-12 point)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: moderate to severe acne scar Exclusion Criteria: taken procedures for acne scar within 6 months underlying diabetes mellitus, keloid, or malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Hun Suh, PhD
Organizational Affiliation
Department of Dermatology, Seoul National University College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Seonguk Min, Msc
Organizational Affiliation
Department of Dermatology, Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Seoul National University College of Medicine
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21276157
Citation
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.
Results Reference
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Clinical Effect of Platelet Rich Plasma Combined With Laser on Scar

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