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

NCT07250165 | Completed

• 1 other identifier: IRB-2024-0959
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rosacea

Keywords

Rosacea

Outcome Measures

Primary Outcomes (2)

• CEA scores

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

  Baseline to Week 9

• CEA success

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

  Baseline to Week 9

Secondary Outcomes (2)

• DLQI score

  Baseline to Week 9

• GAIS score

  Week 9

Other Outcomes (2)

• Patient satisfaction

  Week 9

• Side effects

  Baseline to Week 15

Study Arms (1)

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.

Device: Excel V, Cutera, Brisbane, CA

Interventions

Excel V, Cutera, Brisbane, CA DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, None Selected, 310009, China

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: August 10, 2024
• Primary Completion: April 1, 2025
• Study Completion: July 2, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)