Comparative Study of Low-Energy 1064nm Laser and DPL in Rosacea Treatment

NCT06915636 | Completed

• 1 other identifier: 2025007
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Rosacea is a common skin disease characterized by transient flushing or persistent erythema and vasodilation symptoms on the face. In more severe cases, papules and pustules may appear in the central part of the face. Rosacea can be classified into four subtypes based on clinical manifestations: erythematotelangiectatic type, papulopustular type, rhinophyma type, and ocular rosacea type. Although the pathophysiology of rosacea is not fully understood, it has been found in previous studies that it is related to abnormal neurovascular and immune responses to various stimuli. Since rosacea is essentially chronic and recurrent, its treatment is difficult and usually requires lifelong management through lifestyle changes. The treatment methods vary depending on the severity and clinical subtype. Facial flushing and telangiectasia are common symptoms of rosacea, and they respond well to laser treatment with wavelengths that selectively absorb oxyhemoglobin, such as pulsed dye laser (PDL), intense pulsed light (IPL), and long-pulse Nd:YAG. Alexandrite laser is widely used for pigmented skin lesions and hair removal due to its absorption characteristics within the melanin spectrum. Recently, there has been increasing interest in using Alexandrite laser for treating vascular lesions, especially deeper ones, as it is relatively easily absorbed by deoxyhemoglobin and can penetrate deeper into the dermis than PDL. However, so far, there is little evidence regarding the effectiveness of Alexandrite laser in treating rosacea. In Kim et al.'s only available randomized clinical trial to date, the authors reported that the effect of dual-wavelength Alexandrite/Nd:YAG treatment for rosacea was comparable to that of PDL. The unique photothermal effect of the large-spot low-energy mode of 1064nm Q-switched Nd:YAG laser can enhance endogenous porphyrin activity, inhibit Propionibacterium acnes activity, penetrate deeper into the dermis to reach sebaceous glands, regulate sebum secretion, and promote inflammation absorption. Rosacea mainly presents as dilated capillaries and/or red patches, and this laser's wavelength is located in the peak absorption region of hemoglobin, which selectively absorbs oxyhemoglobin. According to the selective photothermal effect of light, it destroys capillaries and inhibits their formation, thereby promoting inflammation regression and achieving the purpose of preventing and treating post-inflammatory erythema after acne. In addition, its photothermal effect can also stimulate collagen regeneration, stimulate the rearrangement of collagen fibers and elastic fibers, repair the barrier, and reduce the formation of acne-induced depressed scars. DPL is a single narrow-band IPL device that combines the dual advantages of PDL and IPL. Its wavelength range is 500-600 nm, covering two absorption peaks of oxyhemoglobin including 542 nm and 577 nm, achieving higher energy concentration, higher vascular selectivity, and more precise treatment. This also makes it more precise and efficient in treating superficial vascular lesions. In this study, researchers conducted a randomized face-to-face comparison trial of large-spot low-energy 1064nm laser and DPL to explore their clinical efficacy and safety for rosacea and attempted to compare whether there are differences in clinical treatment between the two for rosacea. Participants were involved in the study to assess the outcomes.

Conditions

Rosacea

Keywords

rosacea

Outcome Measures

Primary Outcomes (1)

• IGA score

  The IGA score can be used to estimate the overall severity of the patient's condition. The score ranges from 0 to 4, with higher scores indicating more severe conditions.

  Baseline level, six weeks, twelve weeks

Secondary Outcomes (7)

• CEA score

  Baseline level, six weeks, twelve weeks

• GFSS score

  Baseline level, six weeks, twelve weeks

• patient satisfaction evaluation

  twelve weeks

• erythema index

  Baseline level, six weeks, twelve weeks

• Dermatology Life Quality Index score

  Baseline level, twelve weeks

Study Arms (2)

DPL

EXPERIMENTAL

Half of the face was randomly treated with DPL, with an energy of 6-8 J/cm2, at an interval of 10 days, for a total of 8 treatments.

Other: DPL

Large spot low-energy 1064nm laser

EXPERIMENTAL

One randomly assigned half of the face was treated with a large-spot, low-energy 1064nm laser at an energy of 0.8-1 J/cm², administered at 10-day intervals, for a total of 8 treatment sessions.

Other: DPL

Interventions

DPL OTHER

Half of the face was randomly treated with DPL, with an energy of 6-8 J/cm2, at an interval of 10 days, for a total of 8 treatments.One randomly assigned half of the face was treated with a large-spot, low-energy 1064nm laser at an energy of 0.8-1 J/cm², administered at 10-day intervals, for a total of 8 treatment sessions.

DPL; Large spot low-energy 1064nm laser

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Those with a history of photosensitivity;
• Those who have combined with severe immunological diseases;
• Those with a tendency to form scars;
• Pregnant or lactating women;
• Alcoholics;
• Those with other facial disorders;
• Those with mental illness or mental disorders who cannot cooperate with treatment;
• During pregnancy or lactation;
• Those with serious internal medical diseases;
• Those with poor compliance or non-cooperation in mental disorders.

You may not qualify if:

• Age range: 18 - 60 years old, gender not limited;
• Patients diagnosed with rosacea in bilateral facial lesion areas with basically symmetrical distribution based on dermoscopy and clinical manifestations;
• Patients with good cognitive function and normal mental state;
• Patients with good communication skills;
• Patients who voluntarily participate in this study and sign the informed consent form.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The Second Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, 710000, China

Location

Related Publications (3)

• Ruan J, Zheng Y, Cai S. Efficacy and safety comparison between pulsed dye laser and intense pulsed light configured with different wavelength bands in treating erythematotelangiectatic rosacea. Lasers Med Sci. 2024 Jun 1;39(1):146. doi: 10.1007/s10103-024-04098-9.

  PMID: 38822948 RESULT

• Varughese N, Keller L, Goldberg DJ. Split-face comparison between single-band and dual-band pulsed light technology for treatment of photodamage. J Cosmet Laser Ther. 2016 Aug;18(4):213-6. doi: 10.1080/14764172.2016.1177188.

  PMID: 27183026 RESULT

• Fu Y, Quan Y, Zhao W, Liu Z, Peng J, Pang X, Zhao B, Tan L, Zhou Q, Shao L, Wang H, Hou S. Low-Energy Delicate Pulsed Light Therapy for Sensitive Skin: A Retrospective Study. J Cosmet Dermatol. 2025 Jan;24(1):e16781. doi: 10.1111/jocd.16781.

  PMID: 39780466 RESULT

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Weihui Zeng

  Second Affiliated Hospital of Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 8, 2025
• Study Start: December 7, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)