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CompletedNCT07250165Updated Nov 26, 2025

Combined Therapy of 532-nm KTP and Microsecond 1064-nm Nd:YAG Laser for Rosacea

An interventional study of Excel V, Cutera, Brisbane, CA in Rosacea, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-11-26.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Aug 2024, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Rosacea with a site in China — 8 open to participants now, 9 under way, none of them phase 3. Rosacea · China.

Enrollment
15th of 16
15 · median 55
Started
2024
with 2 others
No phase
13 of 16
6 open now
Registered
9th of 16
by date
Lead sponsor
2 of 16
Second Affiliated Hospital, School of Medicine, Zhejiang University

Among the 16 studies in Rosacea with a site in China, this one is the 15th largest by enrollment, is one of 3 that started in 2024, is one of 13 with no phase, and was the 9th registered.

By phase

16 studies; the count open now beside each. This study's row is marked.

No phasethis study13 · 6 open
Phase 11 · 0 open
Phase 21 · 1 open
Phase 41 · 1 open

By the year they started

First in 2022; this study’s year is marked. 3 started in 2024.

Size and results

Median enrollment 55 across the 16 interventional studies. Of the 6 that completed or were terminated, 0 (0%) have results posted.

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02

Study summary

Rosacea remains a therapeutically challenging, chronic facial dermatosis whose central feature-persistent erythema-often resists topical and systemic agents. In this study we evaluated, for the first time, the simultaneous use of a 532-nm potassium titanyl phosphate (KTP) laser and a microsecond-pulsed 1064-nm Nd:YAG laser as a safe alternative.

Read the detailed description

Rosacea is an extremely common condition characterised by facial flushing, dilated capillaries and papules and pustules. Both systemic and topical treatments have their drawbacks, such as limited efficacy, intolerable adverse reactions, drug resistance and high recurrence rates. Therefore, it is necessary to explore new treatment methods for rosacea.

Lasers have been used for more than three decades to treat vascular lesions with an excellent safety profile and very low risk of scar formation. Purpura was a common side effect of the previous generation of lasers and has been significantly reduced with the introduction of newer devices. The 532-nm potassium titanyl phosphate (KTP) laser is used for treating vascular cutaneous lesions due to its selective absorption by haemoglobinn, while rarely inducing purpura. However, the 532-nm KTP laser is primarily effective for superficial blood vessels. The long-pulsed 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser can penetrate up to 4-6 mm beneath the skin and is effective in treating larger blood vessels. Previous studies have demonstrated that the long-pulsed 1064-nm Nd:YAG laser is effective for both erythematotelangiectatic rosacea (ETR) and papulopustular rosacea (PPR). However, traditional millisecond-domain devices should still be used with caution in darker skin types, and it is associated with an extensive zone of thermal injury and a heightened risk of scar formation. In contrast to millisecond 1064-nm Nd:YAG lasers, microsecond-pulsed lasers deliver energy within the thermal relaxation time of the epidermis, minimizing heat diffusion to surrounding tissues.

Rosacea is a chronic and recurrent dermatologic condition that poses significant therapeutic challenges. While both 532-nm KTP and 1064-nm Nd:YAG lasers demonstrate efficacy in managing rosacea-associated erythema, no single laser system can address all vascular components due to their distinct limitations in penetration depth and vessel selectivity. We need to explore more treatment options. This study aims to evaluate the efficacy and safety of a 532-nm KTP laser combined with a microsecond 1064-nm ND:YAG laser in treating the erythema of rosacea, in order to provide scientific evidence for clinical application.

03

Conditions studied

  • Rosacea

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Keywords

  • Rosacea
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants aged between 18 and 65 years, without cognitive impairments, and of any gender
  • Patients must meet the 2017 rosacea diagnostic criteria updated by the National Rosacea Society Expert Committee
  • The severity of rosacea must be scored at least 2 points on the Clinician's Erythema Assessment (CEA) scale.

Exclusion criteria

Exclusion Criteria:

  • if they had undergone any treatments that could influence the prognosis of rosacea within the preceding 8 weeks
  • if they had taken photosensitizing or phototoxic medications within the same period
  • the presence of other facial conditions that might confound the efficacy assessment
  • participation in any drug clinical trial as a subject within the last month
  • the presence of severe concurrent diseases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Combined 532 nm KTP + microsecond 1064 nm Nd:YAG laser

    Participants are allocated to receive combined dual-wavelength laser therapy (microsecond 1064 nm Nd:YAG followed by 532 nm KTP) in a single session, repeated every 3 weeks for a total of three sessions. No anaesthesia is used.

    Device: Excel V, Cutera, Brisbane, CA

Interventions

  • DeviceExcel V, Cutera, Brisbane, CA

    The facial erythema was treated with 532-nm KTP combined with microsecond 1064-nm ND:YAG laser. Each patient received three consecutive laser treatments with an interval of three weeks . Patients were treated using both laser modules during the same session without anesthesia. Firstly, microsecond 1064-nm Nd:YAG laser (Excel V, Cutera, Brisbane, CA) was applied with an 8 mm spot size, 0.3ms pulse duration, and energy density of 6-7 J/cm². Then, 532-nm KTP laser was used for treatment. When a 10 mm spot size was used, the energy density was 6-9 J/cm² and the pulse duration was 8-15ms; when a 5 mm spot size was used, the energy density was 8-10 J/cm² and the pulse duration was 8-12ms.

06

What researchers measure

Primary outcomes

  1. CEA scores

    Change from baseline in Clinician Erythema Assessment (CEA) at Week 9; scored 0-4 by blinded photograph review.

    Time frame: Baseline to Week 9

  2. CEA success

    A decrease in CEA of 1 or more is considered as a CEA success

    Time frame: Baseline to Week 9

Secondary outcomes

  1. DLQI score

    The Dermatological Life Quality Index (DLQI) is a validated self-reported questionnaire consisting of 10 questions designed to assess how skin disorders affect a patient's quality of life. The maximum possible score for the DLQI is 30, with higher scores indicating a more significant impact on quality of life.

    Time frame: Baseline to Week 9

  2. GAIS score

    The global aesthetic improvement scale (GAIS) was used to score the improvement (0 = worse, 1 = unaltered, 2 = improved, 3 = much improved, 4 = very much improved).

    Time frame: Week 9

Other outcomes

  1. Patient satisfaction

    Patient satisfaction was assessed by the patients themselves, with responses categorized as follows: 1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5 = very dissatisfied.

    Time frame: Week 9

  2. Side effects

    Patients and dermatologists documented any adverse events experienced throughout the study, including pain, heat sensation, erythema, edema, dryness, tightness, itching, purpura, vesicle, hyperpigmentation, hypopigmentation, and scar.

    Time frame: Baseline to Week 15

07

Study locations

1 site
  • Second Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, None Selected 310009, China
08

References and documents

Publications

  • Sun Y, Lou Y, Lao L, Cai S. Combined therapy of 532-nm KTP and microsecond 1064-nm Nd:YAG laser for rosacea. Lasers Med Sci. 2026 Jul 18;41(1):155. doi: 10.1007/s10103-026-04941-1. PubMed 42470571 ↗

Individual participant data

Plan to share: Yes — De-identified participant data (CEA scores, DLQI, GAIS, adverse events) and the study protocol will be made available to qualified researchers beginning 6 months after primary publication. Proposals must be approved by the corresponding author and institution; data will be shared via secure file transfer with a signed data-use agreement.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2024 to primary completion in Apr 2025, 7 months.

Of 42 interventional studies with no phase under Rosacea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2025
First posted
Nov 26, 2025
StartActual
Aug 10, 2024
Primary completionActual
Apr 1, 2025
CompletionActual
Jul 2, 2025
Last update
Nov 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07250165
Responsible party
Yanhong Sun (Attending Physician, Second Affiliated Hospital, School of Medicine, Zhejiang University) — Principal investigator
First posted
Nov 26, 2025
Start date
Aug 10, 2024
Primary completion
Apr 1, 2025
Completion
Jul 2, 2025
Last update
Nov 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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