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Trial record 37 of 82 for:    acne AND Acne Scars

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

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ClinicalTrials.gov Identifier: NCT03850925
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Gyeong-Hun Park, Dongtan Sacred Heart Hospital

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.

Condition or disease Intervention/treatment Phase
Acne Scars Procedure: Laser therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Split-face comparison study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Picosecond Pulsed Nd:YAG Laser and Fractional Laser for the Treatment of Acne Scars
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Experimental: Picosecond laser
Intervention: four consecutive sessions of 1,064-nm picosecond laser at 3-week intervals
Procedure: Laser therapy
4 consecutive sessions of laser therapy

Active Comparator: Fractional laser
Intervention: four consecutive sessions of nonablative fractional laser at 3-week intervals
Procedure: Laser therapy
4 consecutive sessions of laser therapy




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850925


Contacts
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Contact: Gyeong-Hun Park, MD, PhD +82-31-8086-2839 parkgh@hallym.or.kr

Locations
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Korea, Republic of
Dongtan Sacred Heart Hospital, Hallym Universtiy College of Medicine Recruiting
Hwaseong-si, Gyeonggi-do, Korea, Republic of, 18450
Contact: Gyeong-Hun Park, MD, PhD    +82-31-8086-2839    parkgh@hallym.or.kr   
Sponsors and Collaborators
Dongtan Sacred Heart Hospital
Investigators
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Principal Investigator: Gyeong-Hun Park, MD, PhD Dongtan Sacred Heart Hospital, Hallym University College of Medicine

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Responsible Party: Gyeong-Hun Park, Associate professor, Dongtan Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT03850925     History of Changes
Other Study ID Numbers: 2019_02_004
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No