Comparison of Picosecond Pulsed Nd:YAG Laser and Fractional Laser for the Treatment of Acne Scars
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Gyeong-Hun Park, MD, PhD
- Phone Number: +82-31-8086-2839
- Email: parkgh@hallym.or.kr
Study Locations
-
-
Gyeonggi-do
-
Hwaseong-si, Gyeonggi-do, South Korea, 18450
- Dongtan Sacred Heart Hospital, Hallym Universtiy College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Picosecond laser
Intervention: four consecutive sessions of 1,064-nm picosecond laser at 3-week intervals
|
4 consecutive sessions of laser therapy
|
|
Active Comparator: Fractional laser
Intervention: four consecutive sessions of nonablative fractional laser at 3-week intervals
|
4 consecutive sessions of laser therapy
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the mean of the ECCA grading scale
Time Frame: Week 17
|
The ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading scale: minimum score 0; maximum score 270; higher values represent a worse outcome.
|
Week 17
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Gyeong-Hun Park, MD, PhD, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2019_02_004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.