Efficacy and safety of fractional picosecond-domain laser (PSL) for atrophic traumatic and surgical scars : A randomized split-scar study

Phase 1

• Conditions: fractional picosecond-domain laser (PSL) for atrophic traumatic and surgical scars; Atrophic traumatic; Atrophic surgical scars; Fractional picosecond-domain laser

• Registration Number: TCTR20210302003
• Lead Sponsor: Division of Dermatology, Department of internal medicine, Faculty of medicine, Thammasat University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-02
• Study Completion: 2022-01-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Healthy male or female participants, aged 18-65.
2. Participants had s atrophic dramatic scar or atrophic surgical scar more than 2 cm. for more than 1 year in any position of the body.
3. Participants who are willing to join the project after receiving a detailed description of the project and signing a consent form for the study.
4. Participants can follow the testing method to follow up on treatment results throughout the study period and can report side effects that arise from the study immediately.

Exclusion Criteria

1. Participant with a previous history of keloid scars.
2. Participants had a history of using systemic retinoids (acitretin, isotretinoin) within 6 months prior to the start of the study.
3.Participants have a history of treatment for atrophic scar such as topical vitamin A, topical drugs that exfoliate or exfoliate skin, microdermabrasion, and chemical peeling. Before, within 6 months prior to the start of research
4. Participants who are pregnant, breastfeeding, or planning to become pregnant.
5. Participants had a history of connective tissue disease.
6. Participants who took immunosuppressants (Immunosuppressive agents)
7. Participants with any type of diabetes mellitus.
8. Participants with diseases that make ulcers difficult to heal, such as sclerosis, peripheral arterial disease, etc.
9. Participant with infectious conditions in the treated area such as herpes, acne, cellulitis, etc.
10. Participants with a history of local anesthesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
scar volume at 6 months after first of the intervention skin imaging analysis (Antera3Dsystem)

Secondary Outcome Measures

Name	Time	Method
Patient satisfactions at 6 months after first of the intervention Satisfaction assessment form,pain score every time after treatment pain score assessment form,adverse event after treatment every time after treatment adverse event assessment form,The efficacy of the treatment at 6 months after first of the intervention dermatologist,The density of collagen and elastin fibers. at 6 months after first of the intervention skin biopsy