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

NCT05360043 | Unknown

• 1 other identifier: 2022-0073
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Enlarged Facial Pores

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change from baseline in Pore number

  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.

  from baseline(T0) at two months after last treatment(T1)

• Subjective evaluations for improvement in appearance of facial pores

  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%).

  two months after last treatment(T1)

• Satisfaction evaluations for treatment results

  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.

  two months after last treatment(T1)

Secondary Outcomes (2)

• Pain score

  immediately after each laser treatment

• Side effects

  through study completion, an average of 0.5 year

Study Arms (2)

LPNY side

EXPERIMENTAL

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

Device: laser treatment

NAFL side

EXPERIMENTAL

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

Device: laser treatment

Interventions

laser treatment 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.

LPNY side; NAFL side

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University of Medicine

Hanzhou, Zhejiang, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35971017 DERIVED

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Suiqing Cai, Ph.D

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Ying Wang, M.D

CONTACT

+86 15168229499; wangyingme@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: May 4, 2022
• Study Start: October 27, 2018
• Primary Completion: April 5, 2022
• Study Completion: October 1, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)