Comparison of Picosecond Pulsed Nd:YAG Laser and Fraction... | NCT03850925

Studies
Comparison of Picosecond Pulsed Nd:YAG Laser and Fractional Laser for the Treatment of Acne Scars

NCT03850925

Sponsor

Dongtan Sacred Heart Hospital

Status

Unknown status

Last Update Posted

May 2, 2019Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Acne Scars

Interventions

Laser therapy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Apr 30, 2020Estimated

Completion Date

Apr 30, 2020Estimated

First Submitted Date

Feb 20, 2019

First Submission Date that Met QC Criteria

Feb 21, 2019

First Posted Date

Feb 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2019

Last Update Posted Date

May 2, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gyeong-Hun Park, Associate professor, Dongtan Sacred Heart HospitalPrincipal Investigator

Lead Sponsor

Dongtan Sacred Heart HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Laser therapy	Procedure	4 consecutive sessions of laser therapy	Fractional laser Picosecond laser

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gyeong-Hun Park, MD, PhD	Contact	+82-31-8086-2839		parkgh@hallym.or.kr

Overall Officials

Name	Affiliation	Role
Gyeong-Hun Park, MD, PhD	Dongtan Sacred Heart Hospital, Hallym University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dongtan Sacred Heart Hospital, Hallym Universtiy College of Medicine	Recruiting	Hwaseong-si	Gyeonggi-do	18450	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D053685	Laser Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

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Browse Branches

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