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

NCT ID: NCT07250165

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-10
• Study Completion Date: 2025-07-02

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Excel V, Cutera, Brisbane, CA

Intervention Type: 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.

Interventions

Excel 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Yanhong Sun

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, None Selected, China

Countries

China

Other Identifiers

IRB-2024-0959

Identifier Type: -

Identifier Source: org_study_id