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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P-MLA | Experimental | a fractional 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser with MLA handpiece (P-MLA for short) |
|
| AF-Er | Sham Comparator | ablative fractional 2940-nm Er:YAG laser (AF-Er for short) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects of pain, erythema, edema, exudation, pinpoint bleeding and petechiae | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dai Ru, Ph.D | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University, China | Hangzhou | Zhejiang | 310009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38034535 | Derived | 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. |
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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.
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|
| 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. |
|
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 |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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