Comparison of Picosecond Lasers vs. Ablative Fractional Er:YAG Lasers in Treating Atrophic Scar

NCT05686603 | Completed

• 1 other identifier: 20220419
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The 1064-nm Nd:YAG picosecond lasers using fractional micro-lens array (P-MLA) was a promising therapy for skin resurfacing. However, no studies have compared P-MLA with ablative fractional 2940-nm Er:YAG lasers (AF-Er) in treating atrophic acne scars. To evaluate the efficacy and safety of P-MLA and AF-Er for the treatment of atrophic acne scars, we performed a prospective, randomized, split-face, controlled trial. Thirty-one Asian patients underwent four consecutive sessions of randomized split-face treatment with P-MLA and AF-Fr at 4-week intervals.

Conditions

Acne; Atrophic Scar

Keywords

atrophic scar; acne; picosecond laser; ablative laser; efficacy; safety

Outcome Measures

Primary Outcomes (2)

• Efficacy of scar improvement evaluated by investigators

  the Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) grading scale and Investigator's Global Assessment (IGA) scores

  8 weeks after final treatment

• Efficacy of scar improvement evaluated by patients

  a Likert satisfaction scale (1 = very dissatisfied, 2 = dissatisfied, 3 = slightly satisfied, 4 = satisfied, 5 = very satisfied)

  8 weeks after final treatment

Secondary Outcomes (2)

• Adverse effects of pain, erythema, edema, exudation, pinpoint bleeding and petechiae

  Immediately after treatment.

• Adverse effects of crust shedding time, duration of erythema and edema, post inflammatory hyperpigmentation (PIH), scarring formation, pruritus and milia.

  Through study completion, 8 weeks after final treatment

Study Arms (2)

P-MLA

EXPERIMENTAL

a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece (P-MLA for short)

Device: a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece

AF-Er

SHAM COMPARATOR

ablative fractional 2940-nm Er:YAG laser (AF-Er for short)

Device: a ablative fractional 2940-nm Er:YAG laser

Interventions

a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece DEVICE

Picosecond laser is a novel technology characterized by ultra-short, picosecond pulse duration which can be effective for many skin conditions, such as pigmentation, photoaging and wrinkles reduction. When combined with micro-lens array (MLA) optics, high-intensity, micro-injury zones can be generated in the epidermis and dermis, causing optical breakdown of surrounding tissue and stimulating of dermal remodeling with mild side-effects. Previous studies had showed the picosecond lasers with MLA afforded better or similar clinical outcomes as well as fewer side-effects in treating acne scar than non-ablative lasers.

P-MLA

a ablative fractional 2940-nm Er:YAG laser DEVICE

2940-nm erbium yttrium aluminum garnet (Er:YAG) laser is one of the most commonly used treatments for atrophic acne scars, which can remove the damage tissue of the scars and allow collagen remodeling and re-epithelialization.

AF-Er

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years;
• presence with similar atrophic acne scars on both sides of the face;
• signed informed consent and cooperated with the follow up and complied the study protocol.

You may not qualify if:

• a previous history of keloid or hypertrophic scar formation;
• undergone any acne scar treatments in the past 6 months before the first treatment;
• pregnant or lactating females;
• sensitive to lights;
• allergic to lidocaine;
• other preexisting skin conditions or uncontrolled systemic diseases.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

• Dai R, Cao Y, Su Y, Cai S. Comparison of 1064-nm Nd:YAG picosecond laser using fractional micro-lens array vs. ablative fractional 2940-nm Er:YAG laser for the treatment of atrophic acne scar in Asians: a 20-week prospective, randomized, split-face, controlled pilot study. Front Med (Lausanne). 2023 Nov 16;10:1248831. doi: 10.3389/fmed.2023.1248831. eCollection 2023.

  PMID: 38034535 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Dai Ru, Ph.D

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This prospective, randomized, split-face, controlled trial. Enrolled participant was randomized to receive split-face treatment with fractional 1064-nm Nd:YAG picosecond lasers (PicocareTM, Wontech, Korea) on one side and ablative fractional 2940-nm Er:YAG laser (Dermablate MCL31, Asclepion Laser Technologies, Germany) on the other side. The block randomization was used to assign the treatment modality.

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 17, 2023
• Study Start: April 12, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)