NCT03850925

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.

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
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

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

First Submitted

Initial submission to the registry

February 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

February 20, 2019

Last Update Submit

April 30, 2019

Conditions

Acne Scars

Outcome Measures

Primary Outcomes (1)

  • 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.

    Week 17

Study Arms (2)

Picosecond laser

EXPERIMENTAL

Intervention: four consecutive sessions of 1,064-nm picosecond laser at 3-week intervals

Procedure: Laser therapy

Fractional laser

ACTIVE COMPARATOR

Intervention: four consecutive sessions of nonablative fractional laser at 3-week intervals

Procedure: Laser therapy

Interventions

Laser therapyPROCEDURE

4 consecutive sessions of laser therapy

Fractional laserPicosecond laser

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongtan Sacred Heart Hospital, Hallym Universtiy College of Medicine

Hwaseong-si, Gyeonggi-do, 18450, South Korea

RECRUITING

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Gyeong-Hun Park, MD, PhD

    Dongtan Sacred Heart Hospital, Hallym University College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gyeong-Hun Park, MD, PhD

CONTACT

+82-31-8086-2839parkgh@hallym.or.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Split-face comparison study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 22, 2019

Study Start

May 1, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

May 2, 2019

Record last verified: 2019-04

Locations

KR(1)