RosaceaNCT07250165
Combined Therapy of 532-nm KTP and Microsecond 1064-nm Nd:YAG Laser for Rosacea
A study testing Excel V, Cutera, Brisbane, CA in people with Rosacea, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rosacea
- What is being tested?
- Excel V, Cutera, Brisbane, CA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2024to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, None Selected, 310009
About this study
Official title: Prospective, Single-arm, Open-label Study of Efficacy and Safety of 532 nm KTP and Microsecond 1064 nm Nd:YAG Laser in Rosacea
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.
- Conditions
- Rosacea
- Being tested
- Excel V, Cutera, Brisbane, CA
- Keywords
- Rosacea
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excel V, Cutera, Brisbane, CADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined 532 nm KTP + microsecond 1064 nm Nd:YAG laser | Experimental | 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. Receives: Device: Excel V, Cutera, Brisbane, CA |
What is being measured
The primary outcome is the main question the study is designed to answer.
CEA scores
Change from baseline in Clinician Erythema Assessment (CEA) at Week 9; scored 0-4 by blinded photograph review.
Measured: Baseline to Week 9
CEA success
A decrease in CEA of 1 or more is considered as a CEA success
Measured: Baseline to Week 9
Secondary outcomes (2)
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.
Measured: Baseline to Week 9
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).
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start10 Aug 2024
- Primary completion1 Apr 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Sun, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250165
- Sponsor's protocol ID
- IRB-2024-0959
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Open-label Study of Efficacy and Safety of 532 nm KTP and Microsecond 1064 nm Nd:YAG Laser in Rosacea
- ClinicalTrials.gov ID
- NCT07250165
- Acronym / sponsor ID
- IRB-2024-0959
- Conditions
- Rosacea
- Keywords
- Rosacea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined 532 nm KTP + microsecond 1064 nm Nd:YAG laser | Experimental | Device: Excel V, Cutera, Brisbane, CAParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excel V, Cutera, Brisbane, CAThe 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. | Device | Combined 532 nm KTP + microsecond 1064 nm Nd:YAG laser |
Primary outcome
CEA scores
Time frame: Baseline to Week 9
Change from baseline in Clinician Erythema Assessment (CEA) at Week 9; scored 0-4 by blinded photograph review.
CEA success
Time frame: Baseline to Week 9
A decrease in CEA of 1 or more is considered as a CEA success
2 secondary outcomes
DLQI score
Time frame: Baseline to Week 9
GAIS score
Time frame: Week 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Derived from this study: PubMed 42470571Sun 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excel V, Cutera, Brisbane, CA in people with Rosacea, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CEA scores (time frame: Baseline to Week 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07250165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.