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 Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ying Wang, M.D
- Phone Number: +86 15168229499
- Email: wangyingme@zju.edu.cn
Study Locations
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Zhejiang
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Hanzhou, Zhejiang, China
- Recruiting
- The Second Affiliated Hospital of Zhejiang University of Medicine
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Contact:
- Ying Wang, M.D
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: LPNY side
1064-nm LPNY (Gentle YAG, Candela ®, USA)
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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.
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Experimental: NAFL side
1565-nm NAFL(ResurFX mode, M22, Lumenis ®, Yokneam, Israel)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Pore number
Time Frame: from baseline(T0) at two months after last treatment(T1)
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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.
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from baseline(T0) at two months after last treatment(T1)
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Subjective evaluations for improvement in appearance of facial pores
Time Frame: two months after last treatment(T1)
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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%).
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two months after last treatment(T1)
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Satisfaction evaluations for treatment results
Time Frame: two months after last treatment(T1)
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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.
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two months after last treatment(T1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain score
Time Frame: immediately after each laser treatment
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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).
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immediately after each laser treatment
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Side effects
Time Frame: through study completion, an average of 0.5 year
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Any side effects or complications were recorded at each visit, including erythema, edema, and pigmentation, et al.
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through study completion, an average of 0.5 year
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Collaborators and Investigators
Investigators
- Study Director: Suiqing Cai, Ph.D, Second Affiliated Hospital, School of Medicine, Zhejiang University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-0073
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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