Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05686603 |
| Other study ID # |
20220419 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 12, 2022 |
| Est. completion date |
October 31, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
