Pulsed Dye Laser and Intense Pulsed Light Configured With Different Wavelength Bands in Improving Erythematotelangiectatic Rosacea

Comparison of Efficacy and Safety of Pulsed Dye Laser and Intense Pulsed Light Configured With Different Wavelength Bands in the Treatment of Erythematotelangiectatic Rosacea

Pulsed dye laser(PDL) and intense pulsed light(IPL) has been widely used in improving rosacea. To compare the efficacy and safety of PDL and IPL configured with different wavelength bands(Delicate Pulsed Light, M22 590, M22 vascular filter) in the treatment of rosacea, we designed a prospective, randomized controlled trial. We hope to make a comparison between PDL and IPL,between broad-spectrum IPL and narrow-spectrum IPL, between single-band IPL and dual-band IPL, and also provide clinical basis for clinicians and patients to develop individualized treatment plans.

Study Overview

• Status: Recruiting
• Conditions: Erythematotelangiectatic Rosacea
• Intervention / Treatment: Device: PDL(595nm); Device: IPL(DPL); Device: IPL(M22 590); Device: IPL(M22 vascular)

Detailed Description

Rosacea is a chronic skin condition characterized by erythema, inflammatory papules, pustules and telangiectasias, which typically occur on the face of middle-aged adults, especially fair skinned. The disease can lead to social stigmatization and may significantly reduce the quality of life of patients. For erythematous lesions and telangiectasia, intense pulsed light (IPL) therapy and lasers are popular treatmen option. Lasers and non-coherent intense pulse light sources (IPL) are based on the principle of selective photothermolysis. The target chromophore in vascular lesions is the oxyhemoglobin present in the red blood corpuscles (RBCs) which circulates in the blood vessels. Pulsed dye lasers (PDL) use a wavelength of 595 nm and is the gold standard of vascular lesion treatment. A common complication is post treatment purpura which appears immediately and can last for 7-14 days, which may be cosmetically unacceptable. The intense pulsed light (IPL) produces a non-coherent light beam with a spectrum of wavelengths from 500 to 1200 nm. Cut-off filters at 515, 550, 570, 590 nm are used for vascular lesions. To compare the efficacy and safety of PDL and IPL configured with different wavelength bands(Delicate Pulsed Light, M22 590, M22 vascular filter) in the treatment of rosacea, we designed a prospective, randomized controlled trial. We hope to make a comparison between PDL and IPL,between broad-spectrum IPL and narrow-spectrum IPL, between single-band IPL and dual-band IPL, and also provide clinical basis for clinicians and patients to develop individualized treatment plans.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jiali J Ruan, postgraduate; Phone Number: 86 19883117589; Email: 22018542@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China, 0571
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University of Medicine
      • Contact: Suiqing S Cai, doctor; Phone Number: 13957107910; Email: 2191008@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

age of at least 18 years; according to the rosacea diagnostic criteria established by the NRSEC in 2002, be diagnosed as erythematotelangiectatic rosacea; Rosacea clinical score is between 9 and 12; Fitzpatrick skin type III and IV;

Exclusion Criteria:

there was infection in the treatment site sunburn history within 1 month; received oral isotretinoin or laser treatment in the past 3 months received chemical peeling 1 month before the study pregnancy or breast-feeding. those who are receiving other treatment for rosacea, such as topical and oral drugs;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsed dye laser(PDL); The patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter	Device: PDL(595nm); One subject was treated with pulsed dye laser (Vbeam platinum, 595 nm, Candela Corporation): energy dosages of 9-11 J/cm2, pulse durations of 10/20 ms, and spot size of 7 mm.
Experimental: IPL(Delicate Pulsed Light); The patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter	Device: IPL(DPL); One subject was treated with IPL(delicate Pulsed Light, Dye-VL, Alma Lasers Corporation): energy dosages of 8.4-10.6 J/cm2, pulse durations of 10/12 ms, and spot size of 10×30 mm.
Experimental: IPL(M22 590); The patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter	Device: IPL(M22 590); One subject was treated with IPL(M22 590, 590-1200nm, Lumenis Limited): energy dosages of 15-18 J/cm2, pulse durations of 3-4 ms, pulse delay of 30-40 ms, and spot size of 15×35 mm.
Experimental: IPL(M22 vascular filter); The patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter	Device: IPL(M22 vascular); One subject was treated with IPL(M22 vascular, 530-650nm and 900-1200nm, Lumenis Limited): energy dosages of 9-17 J/cm2, pulse durations of 4-6 ms, pulse delay of 20-40 ms, and spot size of 15×35 mm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rosacea clinical score	It includes objective symptom score(Flushing, Nontransient erythema, Telangiectasia) and subjective symptom score(Burning or stinging, Itching, Dry), with a 4-level score according to the standard grading system by NRS. Objective symptom is assessed by a dermatologist, and subjective symptom score is assessed by subjects themselves.	from baseline(T0) to 4weeks after the final treatment(T3)
VISIA Red Area score	using VISIA image system to record red area absolute score	from baseline(T0) to 4weeks after the final treatment(T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	It is evaluated by subjects themselves with Visual analogue scale(VAS) , on a scale hypopigmentation were recorded.	immediately after each laser treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse effects	Adverse reactions such as pain, erythema and edema, hyperpigmentation and hypopigmentation were recorded.	through study completion, an average of 0.5 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Suiqing S Cai, doctor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2022
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: April 30, 2022
• First Submitted That Met QC Criteria: April 30, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Pulsed dye laser，intense pulse light
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: 2022-0177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Since the individual participant data(IPD) is personal information, our participants are unwilling to share. But we welcome any questions through emails.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No