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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2022
CompletedFirst Submitted
Initial submission to the registry
April 30, 2022
CompletedFirst Posted
Study publicly available on registry
May 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedMay 4, 2022
March 1, 2022
3 months
April 30, 2022
April 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Pain score
immediately after each laser treatment
Other Outcomes (1)
adverse effects
through study completion, an average of 0.5 year
Study Arms (4)
Pulsed dye laser(PDL)
EXPERIMENTALThe patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter
IPL(Delicate Pulsed Light)
EXPERIMENTALThe patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter
IPL(M22 590)
EXPERIMENTALThe patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter
IPL(M22 vascular filter)
EXPERIMENTALThe patients were randomly categorized into the following four groups based on the treatments they received: PDL, DPL, M22 590, M22 vascular filter
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital of Zhejiang University of Medicine
Hanzhou, Zhejiang, 0571, China
Related Publications (1)
Ruan J, Zheng Y, Cai S. Efficacy and safety comparison between pulsed dye laser and intense pulsed light configured with different wavelength bands in treating erythematotelangiectatic rosacea. Lasers Med Sci. 2024 Jun 1;39(1):146. doi: 10.1007/s10103-024-04098-9.
PMID: 38822948DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Suiqing S Cai, doctor
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- patients are blinded to laser therapy received
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2022
First Posted
May 4, 2022
Study Start
March 27, 2022
Primary Completion
June 30, 2022
Study Completion
July 1, 2022
Last Updated
May 4, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share
Since the individual participant data(IPD) is personal information, our participants are unwilling to share. But we welcome any questions through emails.