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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03850925
Other study ID # 2019_02_004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date April 30, 2020

Study information

Verified date April 2019
Source Dongtan Sacred Heart Hospital
Contact Gyeong-Hun Park, MD, PhD
Phone +82-31-8086-2839
Email parkgh@hallym.or.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Laser therapy
4 consecutive sessions of laser therapy

Locations

Country Name City State
Korea, Republic of Dongtan Sacred Heart Hospital, Hallym Universtiy College of Medicine Hwaseong-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Dongtan Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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