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

Zhejiang University

Status: Enrolling

Conditions: Erythematotelangiectatic Rosacea

Treatments: Device: IPL(M22 590); Device: IPL(DPL); Device: PDL(595nm); Device: IPL(M22 vascular)

Study type: Interventional

Funder types: Other

Identifiers

NCT05360251

2022-0177

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 4 patient groups

Pulsed dye laser(PDL)

Experimental group

Description:

The patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter

Treatment:

Device: PDL(595nm)

IPL(Delicate Pulsed Light)

Experimental group

Description:

The patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter

Treatment:

Device: IPL(DPL)

IPL(M22 590)

Experimental group

Description:

The patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter

Treatment:

Device: IPL(M22 590)

IPL(M22 vascular filter)

Experimental group

Description:

The patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter

Treatment:

Device: IPL(M22 vascular)