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AcneNCT05686603

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

A study testing a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece and a ablative fractional 2940-nm Er:YAG laser in people with Acne and Atrophic Scar, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Acne, Atrophic Scar
What is being tested?
a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece and a ablative fractional 2940-nm Er:YAG laser
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteChina
Study dates
12 Apr 2022to 31 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Second Affiliated Hospital, School of Medicine, Zhejiang University, China

    Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: Comparison of 1064nm Nd:YAG Picosecond Lasers Using Fractional Micro-lens Array vs. Ablative Fractional 2940nm Er:YAG Lasers for the Treatment of Atrophic Acne Scar in Asians: a 20-week Prospective, Randomized, Split-face, Controlled Trial

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.

Read the detailed description

Acne is a common skin disorder affecting 9.38% of the global population, especially among adolescents and young adults. One publication showed that 43% of cases with facial acne could develop scars, and the acne-associated scarring often has a negative effect on patients' psychosocial and physical well-being. A wide range of interventions have been proposed to treat atrophic acne scars, including laser, chemical peels, dermabrasion, injectable fillers and surgical methods. 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. However, there are insufficient prospective comparative studies evaluating the picosecond laser with MLA optics vs. current fractional ablative techniques for the treatment of atrophic acne scars.In this study, we reported a prospective, randomized, split-face, controlled trial that comparing the efficacy and safety of a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece (P-MLA) and ablative fractional 2940-nm Er:YAG laser (AF-Er) for the treatment of atrophic acne scars in Asians.

  1. Study design This prospective, randomized, split-face, controlled trial was approved by the Human Ethics Committee of Zhejiang University School of Medicine Second Affiliated Hospital (2022-0419) and performed in accordance with the Declaration of Helsinki. Written informed consent was obtained from all subjects before enrollment.
  2. Patient selection A total of thirty-three subjects (16 males and 17 females) aged above 18 years of Fitzpatrick skin types II to type V, with mild to moderate atrophic acne scars were recruited for this study. Inclusion criteria for this study were as follows: (1) age ≥18 years; (2) presence with similar atrophic acne scars on both sides of the face; (3) signed informed consent and cooperated with the follow up and complied the study protocol. Subjects were excluded if they had a previous history of keloid or hypertrophic scar formation, undergone any acne scar treatments in the past 6 months before the first treatment, were pregnant or lactating females, were sensitive to lights, were allergic to lidocaine, had other preexisting skin conditions or uncontrolled systemic diseases.
  3. Treatment 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.
  4. Assessment Thorough history taking and physical examination were performed in all subjects. Efficacy and safety of the treatments were evaluated at each visit, and VISIA images (Visia CR®; Canfield Scientific, Parsippany, NJ, USA) of front, left and right face were also obtained at both baseline and last visit for final analyses.

Efficacy Efficacy of scar improvement was evaluated by investigators and patients. A blinded investigator assessed the clinical efficacy by the Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) grading scale and Investigator's Global Assessment (IGA) scores. ECCA score is calculated on the sum of the number and type of scar (V-type, U-type and M-type)(13). IGA was evaluated using a 5-point scale as follows: 0 = no improvement; 1 = 1-25% improvement; 2 = 26-50% improvement; 3 = 51-75% improvement; 4 = 76-100% improvement. Patients rated their degree of satisfaction about scar improvement, pore, skin texture and overall improvement using a Likert satisfaction scale (1 = very dissatisfied, 2 = dissatisfied, 3 = slightly satisfied, 4 = satisfied, 5 = very satisfied). The primary endpoints were the change of ECCA score, IGA score and degree of patient's satisfaction at the final visit compared the baseline score. We also used VISIA system to evaluate the pore and skin texture objectively.

Safety Patients were evaluated at each session immediately for adverse effects including pain, erythema, edema, exudation, pinpoint bleeding and petechiae. The pain was evaluated using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (unbearable pain). Other immediate adverse effects were recorded with a 0-to-3 severity scale (0 = none; 1 = mild; 2 = moderate; 3 = severe). At next follow-up, patients were also asked to record and document their recovery times and possible long-term adverse effects, including crust shedding time, duration of erythema and edema, post inflammatory hyperpigmentation (PIH), scarring formation, pruritus and milia.

Conditions
Acne, Atrophic Scar
Being tested
a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece, a ablative fractional 2940-nm Er:YAG laser
Keywords
atrophic scar, acne, picosecond laser, ablative laser, efficacy, safety
Medical subject headings
Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

  • a ablative fractional 2940-nm Er:YAG laserDevice

    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.

Study groups in NCT05686603
Study groupRoleWhat they receive
P-MLAExperimentala fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece (P-MLA for short)
Receives: Device: a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece
AF-ErSham comparatorablative fractional 2940-nm Er:YAG laser (AF-Er for short)
Receives: Device: a ablative fractional 2940-nm Er:YAG laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 8 weeks after final treatment

  2. Efficacy of scar improvement evaluated by patients

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

    Measured: 8 weeks after final treatment

Secondary outcomes (2)
  1. Adverse effects of pain, erythema, edema, exudation, pinpoint bleeding and petechiae

    Pain, erythema, edema, exudation, pinpoint bleeding and petechiae

    Measured: Immediately after treatment.

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

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

    Measured: Through study completion, 8 weeks after final treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2023
  2. Study start12 Apr 2022
  3. Primary completion30 Sep 2022
  4. Study completion31 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05686603
Sponsor's protocol ID
20220419
Status last verified
Apr 2022
First submitted
9 Jan 2023
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38034535

Questions about this trial

What is this clinical trial studying?

A study testing a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece and a ablative fractional 2940-nm Er:YAG laser in people with Acne and Atrophic Scar, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of scar improvement evaluated by investigators (time frame: 8 weeks after final treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05686603, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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