Back to resultsComparison of Picosecond Pulsed Nd:YAG Laser and Fractional Laser for the Treatment of Acne Scars
Primary Purpose
Acne Scars
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars
Eligibility Criteria
Inclusion Criteria:
- Subjects with facial atrophic acne scars
- Subjects who observe the schedules and protocols of the clinical trial
- Subjects who give informed consent to participate in the clinical trial
Exclusion Criteria:
- Subjects who have active acne under treatment
- Subjects who had received any other treatments for acne scarring for 6 months prior to the first treatment
- Subjects who underwent other treatments including chemical, mechanical or laser resurfacing during the study period
- Subjects who have current acute illness
- Subjects who are considered inappropriate for the clinical trial under the judgement of investigators
Sites / Locations
- Dongtan Sacred Heart Hospital, Hallym Universtiy College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Picosecond laser
Fractional laser
Arm Description
Intervention: four consecutive sessions of 1,064-nm picosecond laser at 3-week intervals
Intervention: four consecutive sessions of nonablative fractional laser at 3-week intervals
Outcomes
Primary Outcome Measures
Changes in the mean of the ECCA grading scale
The ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading scale: minimum score 0; maximum score 270; higher values represent a worse outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT03850925
First Posted
February 20, 2019
Last Updated
April 30, 2019
Sponsor
Dongtan Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03850925
Brief Title
Comparison of Picosecond Pulsed Nd:YAG Laser and Fractional Laser for the Treatment of Acne Scars
Official Title
Comparison of Picosecond Pulsed Nd:YAG Laser and Fractional Laser for the Treatment of Acne Scars
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongtan Sacred Heart Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study compares the application of a picosecond 1064-nm laser with a diffractive lens array with nonablative fractional laser for the treatment of acne scarring.
Detailed Description
This trial is a 17-week, prospective, randomized split-face study that compares the results between two facial sides either receiving the picosecond 1064-nm laser or nonablative fractional laser treatment for atrophic acne scar.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split-face comparison study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Picosecond laser
Arm Type
Experimental
Arm Description
Intervention: four consecutive sessions of 1,064-nm picosecond laser at 3-week intervals
Arm Title
Fractional laser
Arm Type
Active Comparator
Arm Description
Intervention: four consecutive sessions of nonablative fractional laser at 3-week intervals
Intervention Type
Procedure
Intervention Name(s)
Laser therapy
Intervention Description
4 consecutive sessions of laser therapy
Primary Outcome Measure Information:
Title
Changes in the mean of the ECCA grading scale
Description
The ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading scale: minimum score 0; maximum score 270; higher values represent a worse outcome.
Time Frame
Week 17
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with facial atrophic acne scars
Subjects who observe the schedules and protocols of the clinical trial
Subjects who give informed consent to participate in the clinical trial
Exclusion Criteria:
Subjects who have active acne under treatment
Subjects who had received any other treatments for acne scarring for 6 months prior to the first treatment
Subjects who underwent other treatments including chemical, mechanical or laser resurfacing during the study period
Subjects who have current acute illness
Subjects who are considered inappropriate for the clinical trial under the judgement of investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gyeong-Hun Park, MD, PhD
Phone
+82-31-8086-2839
Email
parkgh@hallym.or.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gyeong-Hun Park, MD, PhD
Organizational Affiliation
Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongtan Sacred Heart Hospital, Hallym Universtiy College of Medicine
City
Hwaseong-si
State/Province
Gyeonggi-do
ZIP/Postal Code
18450
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gyeong-Hun Park, MD, PhD
Phone
+82-31-8086-2839
Email
parkgh@hallym.or.kr
12. IPD Sharing Statement
Learn more about this trial
Comparison of Picosecond Pulsed Nd:YAG Laser and Fractional Laser for the Treatment of Acne Scars
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