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
- Conditions
- Enlarged Facial Pores
- Interventions
- Device: laser treatment
- Registration Number
- NCT05360043
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 27
- subjects with enlarged facial pores who were screened by a designated dermatologist
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LPNY side laser treatment 1064-nm LPNY (Gentle YAG, Candela ®, USA) NAFL side laser treatment 1565-nm NAFL(ResurFX mode, M22, Lumenis ®, Yokneam, Israel)
- Primary Outcome Measures
Name Time Method Subjective evaluations for improvement in appearance of facial pores two 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%).
Change from baseline in Pore number from 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.
Satisfaction evaluations for treatment results two 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.
- Secondary Outcome Measures
Name Time Method Pain score immediately after each laser treatment Subjects 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 effects through study completion, an average of 0.5 year Any side effects or complications were recorded at each visit, including erythema, edema, and pigmentation, et al.
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Zhejiang University of Medicine
🇨🇳Hanzhou, Zhejiang, China