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Efficacy and Safety of 1565-nm Non-ablative Fractional Laser Versus Long-pulsed 1064-nm Nd:YAG Laser in the Treatment of Enlarged Facial Pores

Efficacy and Safety of 1565-nm Non-ablative Fractional Laser Versus Long-pulsed 1064-nm Nd:YAG Laser in the Treatment of Enlarged Facial Pores

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05360043
Enrollment
27
Registered
2022-05-04
Start date
2018-10-27
Completion date
2022-10-31
Last updated
2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enlarged Facial Pores

Keywords

Facial pores, Non-ablative fractional laser, Long-pulsed Nd:YAG laser

Brief summary

Facial pores are visible openings of pilosebaceous follicles, it is one of the important factors that affect the appearance of facial skin. This study aims to evaluate and compare the Efficacy and safety of 1565 nm non-ablative fractional laser (NAFL) and long-pulsed 1064 nm Nd:YAG laser (LPNY) in the treatment of enlarged facial pores.

Detailed description

Facial pores are visible openings of pilosebaceous follicles. These openings are not fixed structures and they can be affected by many factors, including sebum secretion, skin elasticity, hair thickness, age, hormones and ultraviolet exposure. These enlarged pores remain a cosmetic problem that impacts patient quality of life. At present, there is no unified evaluation standard for enlarged facial pores, and the mechanisms that underline enlarged facial pores remain unclear. Various methods have been used to treat enlarged facial pores mainly focus on the possible causes. Treatment options include topical retinoic acid, oral isotretinoin, antiandrogen therapy, injections of botulinum toxin type A, chemical peeling, lasers, radiofrequency, and ultrasound devices. In recent years, various studies on laser treatments of facial pores are gradually increasing because of good efficacy and limited adverse reactions. The 1064-nm LPNY has been widely used for facial rejuvenation. Many studies have confirmed that LPNY can reduce facial wrinkles and improve skin elasticity. Some researchers have used it to treat enlarged pores, and it has shown good results. Recently, 1565-nm NAFL is introduced for skin resurfacing, it has also been shown to be effective in treating enlarged facial pores. However, there are not enough clinical researches to confirm their efficacy, and no study has compared these two laser treatments before. So this is the first self-comparative study to compare the safety and efficacy of two lasers in the treatment of enlarged facial pores.

Interventions

DEVICElaser treatment

All subjects were treated with a 1565-nm NAFL on their left faces for one pass, A 34-40 mJ per microbeam laser was used, and density was 250-300 microbeam per cm2. Their right faces were treated with a 1064-nm LPNY for one pass. We used a spot size of 10 mm in diameter, an energy density of 45-50 J/cm2, pulse width of 300 microseconds, and a repetition rate of 2 Hz. 1064-nm LPNY was equipped with a dynamic cooling device (DCD), the parameter was set as 40/20/0 ms. A total of 5 treatments were carried out at 2-week intervals, and one follow-up session at two months after last treatment. Before each treatment, subjects were asked to wash their face with clean water, and no topical lotion was applied. For post-treatment care, all subjects were advised to use their own moisturizing cream and avoid sun exposure.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* subjects with enlarged facial pores who were screened by a designated dermatologist

Exclusion criteria

* infectious skin disease or systemic disease; skin tumors; pregnancy and lactation; patients with a history of glucocorticoids, immunosuppressant drugs and other drugs within 4 weeks; a history of keloid; a medical history of chemical peelings, filler injections, plastic surgery, or laser therapy on the face in the last 3 months

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction evaluations for treatment resultstwo months after last treatment(T1)Subjects rated their satisfaction with the treatment results, using a Likert satisfaction scale (1-5). 1=Very dissatisfied; 2=Dissatisfied; 3=Neither satisfied nor dissatisfied; 4=Satisfied; 5=Very satisfied.
Change from baseline in Pore numberfrom baseline(T0) at two months after last treatment(T1)The VISIA Complexion Analysis System was used to take photos of both facial sides. The system can automatically measure the number of pores. When pore size is smaller or less visible, the system will not detect it, and the pore count will be lower.
Subjective evaluations for improvement in appearance of facial porestwo months after last treatment(T1)Subjects were asked to evaluate the improvement of pore appearance after each treatment and follow-up, rated on a 4-point grading scale. 0=No significant change (0-10%); 1=Mild improvement (11-25%); 2=Moderate improvement (26-50%); 3=Marked improvement (51-75%); 4=Very significant improvement (76-100%).

Secondary

MeasureTime frameDescription
Pain scoreimmediately after each laser treatmentSubjects were asked to rate the degree of pain post-treatment using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (unbearable pain).
Side effectsthrough study completion, an average of 0.5 yearAny side effects or complications were recorded at each visit, including erythema, edema, and pigmentation, et al.

Countries

China

Contacts

Primary ContactYing Wang, M.D
wangyingme@zju.edu.cn+86 15168229499

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026