Clinical trial NCT05360043: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enlarged Facial Pores
Keywords: Facial pores
Non-ablative fractional laser
Long-pulsed Nd:YAG laser
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in Pore number
timeFrame: from baseline(T0) at two months after last treatment(T1)
measure: Subjective evaluations for improvement in appearance of facial pores
timeFrame: two months after last treatment(T1)
measure: Satisfaction evaluations for treatment results
timeFrame: two months after last treatment(T1)
Secondary outcomes:
measure: Pain score
timeFrame: immediately after each laser treatment
measure: Side effects
timeFrame: through study completion, an average of 0.5 year
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Suiqing Cai, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.