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

NCT ID: NCT05360043

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-27
• Study Completion Date: 2022-10-31

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.

Conditions

Enlarged Facial Pores

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LPNY side

1064-nm LPNY (Gentle YAG, Candela ®, USA)

Group Type: EXPERIMENTAL

laser treatment

Intervention Type: DEVICE

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.

NAFL side

1565-nm NAFL(ResurFX mode, M22, Lumenis ®, Yokneam, Israel)

Group Type: EXPERIMENTAL

laser treatment

Intervention Type: DEVICE

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.

Interventions

laser 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suiqing Cai, Ph.D

Role: STUDY_DIRECTOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

The Second Affiliated Hospital of Zhejiang University of Medicine

Hanzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Wang, M.D

Role: CONTACT

wangyingme@zju.edu.cn

+86 15168229499

Facility Contacts

Ying Wang, M.D

Role: primary

References

Wang Y, Zheng Y, Cai S. Efficacy and safety of 1565-nm non-ablative fractional laser versus long-pulsed 1064-nm Nd:YAG laser in treating enlarged facial pores. Lasers Med Sci. 2022 Oct;37(8):3279-3284. doi: 10.1007/s10103-022-03622-z. Epub 2022 Aug 15.

Reference Type: DERIVED

PMID: 35971017 (View on PubMed)

Other Identifiers

2022-0073

Identifier Type: -

Identifier Source: org_study_id