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

Primary Purpose

Erythematotelangiectatic Rosacea

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PDL(595nm)
IPL(DPL)
IPL(M22 590)
IPL(M22 vascular)
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erythematotelangiectatic Rosacea focused on measuring Pulsed dye laser,intense pulse light

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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;

Sites / Locations

  • The Second Affiliated Hospital of Zhejiang University of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Pulsed dye laser(PDL)

IPL(Delicate Pulsed Light)

IPL(M22 590)

IPL(M22 vascular filter)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
VISIA Red Area score
using VISIA image system to record red area absolute score

Secondary Outcome Measures

Pain score
It is evaluated by subjects themselves with Visual analogue scale(VAS) , on a scale hypopigmentation were recorded.

Full Information

First Posted
April 30, 2022
Last Updated
April 30, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05360251
Brief Title
Pulsed Dye Laser and Intense Pulsed Light Configured With Different Wavelength Bands in Improving Erythematotelangiectatic Rosacea
Official Title
Comparison of Efficacy and Safety of Pulsed Dye Laser and Intense Pulsed Light Configured With Different Wavelength Bands in the Treatment of Erythematotelangiectatic Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythematotelangiectatic Rosacea
Keywords
Pulsed dye laser,intense pulse light

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
adult patients diagnosed with erythematotelangiectatic rosacea
Masking
Participant
Masking Description
patients are blinded to laser therapy received
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulsed dye laser(PDL)
Arm Type
Experimental
Arm Description
The patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter
Arm Title
IPL(Delicate Pulsed Light)
Arm Type
Experimental
Arm Description
The patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter
Arm Title
IPL(M22 590)
Arm Type
Experimental
Arm Description
The patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter
Arm Title
IPL(M22 vascular filter)
Arm Type
Experimental
Arm Description
The patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter
Intervention Type
Device
Intervention Name(s)
PDL(595nm)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
IPL(DPL)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
IPL(M22 590)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
IPL(M22 vascular)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rosacea clinical score
Description
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.
Time Frame
from baseline(T0) to 4weeks after the final treatment(T3)
Title
VISIA Red Area score
Description
using VISIA image system to record red area absolute score
Time Frame
from baseline(T0) to 4weeks after the final treatment(T3)
Secondary Outcome Measure Information:
Title
Pain score
Description
It is evaluated by subjects themselves with Visual analogue scale(VAS) , on a scale hypopigmentation were recorded.
Time Frame
immediately after each laser treatment
Other Pre-specified Outcome Measures:
Title
adverse effects
Description
Adverse reactions such as pain, erythema and edema, hyperpigmentation and hypopigmentation were recorded.
Time Frame
through study completion, an average of 0.5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jiali J Ruan, postgraduate
Phone
19883117589
Ext
86
Email
22018542@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suiqing S Cai, doctor
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhejiang University of Medicine
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
0571
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suiqing S Cai, doctor
Phone
13957107910
Email
2191008@zju.edu.cn

12. IPD Sharing Statement

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

Learn more about this trial

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

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