Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05360251 |
Other study ID # |
2022-0177 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 27, 2022 |
Est. completion date |
July 2022 |
Study information
Verified date |
March 2022 |
Source |
Second Affiliated Hospital, School of Medicine, Zhejiang University |
Contact |
jiali J Ruan, postgraduate |
Phone |
19883117589 |
Email |
22018542[@]zju.edu.cn |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
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.