Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Study
Primary Purpose
Rosacea
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
532nm KTP
585nm PDL
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
Eligibility Criteria
Inclusion Criteria: Men and women 18 years and older Good general health, no relevant previous diseases Presence of rosacea Cognitive ability and willingness to give consent (Informed Consent) Exclusion Criteria: Age < 18 years Pregnant and breastfeeding women Significant open wounds or lesions of the region to be treated Metallic implants in the region to be treated Missing consent and/or data protection declarations
Sites / Locations
- Laser Department, University Medical-Center Hamburg-EppendorfRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Potassium Titanyle Phosphate (KTP) Laser
Pulsed Dye Laser
Arm Description
Subjects will be treated with a KTP laser in 1 - 3 sessions at intervals of 4 - 6 weeks.
Subjects will be treated with a PDL in 1 - 3 sessions at intervals of 4 - 6 weeks.
Outcomes
Primary Outcome Measures
reduction of erythema
assessment scale 0 - 4 (normal skin - severe erythema) evaluated by physician and blinded investigator
pain intensity
using numeric rating scale 0 - 10 (none - unbearable pain) evaluated by subjects
swelling
assessment scale 1 - 6 (very - none) evaluated by subjects
purpura
assessment scale 1 - 6 (very - none) evaluated by subjects
Secondary Outcome Measures
patient satisfaction
assessment scale 1 - 6 (very - not at all) evaluated by subjects
Full Information
NCT ID
NCT05771298
First Posted
March 5, 2023
Last Updated
March 5, 2023
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT05771298
Brief Title
Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Study
Official Title
Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Case-Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
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
To compare the efficacy and safety of 532 nm KTP and 585 nm PDL for treating rosacea.
Detailed Description
Rosacea is a common, chronic inflammatory skin disease that usually affects the cheeks, nose, forehead, and chin [1]. Clinically, it presents initially with transient erythema (flushing) and telangiectasia. As it progresses, persistent erythema and papules and pustules appear. Phymatous changes result from hypertrophy of the sebaceous glands, and usually manifest as rhinophyma, gnatophyma, and metophyma [2]. Depending on the literature, rosacea has a prevalence of 1% to 22% [3]. Time of manifestation of the disease is usually between 30 and 50 years [4]. Women are more frequently affected [4].
For laser treatment of rosacea, the pulsed dye laser (PDL) with a wavelength of 595nm is frequently used. The treatment includes at least three sessions at intervals of about 4 weeks and leads to lightening and reduction of the lesions as well as reduction of papules and pustules. Various clinical studies have already demonstrated the high efficacy of PDL [5-7]. The treatment is painless, and local or general anesthesia is not necessary.
The KTP laser is also an option in the treatment of rosacea. Due to the more stable technology of the frequency-doubled Nd:YAG (KTP) and associated lower maintenance problems, this laser system appears to be a safer and more reliable treatment option for rosacea patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Potassium Titanyle Phosphate (KTP) Laser
Arm Type
Other
Arm Description
Subjects will be treated with a KTP laser in 1 - 3 sessions at intervals of 4 - 6 weeks.
Arm Title
Pulsed Dye Laser
Arm Type
Other
Arm Description
Subjects will be treated with a PDL in 1 - 3 sessions at intervals of 4 - 6 weeks.
Intervention Type
Device
Intervention Name(s)
532nm KTP
Intervention Description
one to three treatment sessions
Intervention Type
Device
Intervention Name(s)
585nm PDL
Intervention Description
one to three treatment sessions
Primary Outcome Measure Information:
Title
reduction of erythema
Description
assessment scale 0 - 4 (normal skin - severe erythema) evaluated by physician and blinded investigator
Time Frame
at follow-up visit 4 weeks after last treatment session
Title
pain intensity
Description
using numeric rating scale 0 - 10 (none - unbearable pain) evaluated by subjects
Time Frame
at follow-up visit 4 weeks after last treatment session
Title
swelling
Description
assessment scale 1 - 6 (very - none) evaluated by subjects
Time Frame
at follow-up visit 4 weeks after last treatment session
Title
purpura
Description
assessment scale 1 - 6 (very - none) evaluated by subjects
Time Frame
at follow-up visit 4 weeks after last treatment session
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
assessment scale 1 - 6 (very - not at all) evaluated by subjects
Time Frame
at follow-up visit 4 weeks after last treatment session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women 18 years and older
Good general health, no relevant previous diseases
Presence of rosacea
Cognitive ability and willingness to give consent (Informed Consent)
Exclusion Criteria:
Age < 18 years
Pregnant and breastfeeding women
Significant open wounds or lesions of the region to be treated
Metallic implants in the region to be treated
Missing consent and/or data protection declarations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
L Nguyen, MD
Phone
+49 (0)40 7410-0
Email
l.nguyen@uke.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L Nguyen, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laser Department, University Medical-Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L Nguyen, MD
Phone
040 7410 0
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25919144
Citation
van Zuuren EJ, Fedorowicz Z, Carter B, van der Linden MM, Charland L. Interventions for rosacea. Cochrane Database Syst Rev. 2015 Apr 28;2015(4):CD003262. doi: 10.1002/14651858.CD003262.pub5.
Results Reference
background
PubMed Identifier
29091565
Citation
van Zuuren EJ. Rosacea. N Engl J Med. 2017 Nov 2;377(18):1754-1764. doi: 10.1056/NEJMcp1506630. No abstract available.
Results Reference
background
PubMed Identifier
24229634
Citation
Tan J, Berg M. Rosacea: current state of epidemiology. J Am Acad Dermatol. 2013 Dec;69(6 Suppl 1):S27-35. doi: 10.1016/j.jaad.2013.04.043.
Results Reference
background
PubMed Identifier
20586834
Citation
Elewski BE, Draelos Z, Dreno B, Jansen T, Layton A, Picardo M. Rosacea - global diversity and optimized outcome: proposed international consensus from the Rosacea International Expert Group. J Eur Acad Dermatol Venereol. 2011 Feb;25(2):188-200. doi: 10.1111/j.1468-3083.2010.03751.x. Epub 2010 Jun 25.
Results Reference
background
PubMed Identifier
30285506
Citation
Kim BY, Moon HR, Ryu HJ. Comparative efficacy of short-pulsed intense pulsed light and pulsed dye laser to treat rosacea. J Cosmet Laser Ther. 2019 Aug;21(5):291-296. doi: 10.1080/14764172.2018.1528371. Epub 2018 Oct 4.
Results Reference
background
PubMed Identifier
32141785
Citation
Osman M, Shokeir HA, Hassan AM, Atef Khalifa M. Pulsed dye laser alone versus its combination with topical ivermectin 1% in treatment of Rosacea: a randomized comparative study. J Dermatolog Treat. 2022 Feb;33(1):184-190. doi: 10.1080/09546634.2020.1737636. Epub 2020 Mar 12.
Results Reference
background
PubMed Identifier
29635699
Citation
Bernstein EF, Schomacker K, Paranjape A, Jones CJ. Pulsed dye laser treatment of rosacea using a novel 15 mm diameter treatment beam. Lasers Surg Med. 2018 Oct;50(8):808-812. doi: 10.1002/lsm.22819. Epub 2018 Apr 10.
Results Reference
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Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Study
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