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

April 30, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hanzhou, Zhejiang, China, 0571
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rosacea clinical score
Time Frame: from baseline(T0) to 4weeks after the final treatment(T3)
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
Time Frame: from baseline(T0) to 4weeks after the final treatment(T3)
using VISIA image system to record red area absolute score
from baseline(T0) to 4weeks after the final treatment(T3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: immediately after each laser treatment
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
adverse effects
Time Frame: through study completion, an average of 0.5 year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Suiqing S Cai, doctor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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