Clinical trial NCT05771298: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Rosacea
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: reduction of erythema
timeFrame: at follow-up visit 4 weeks after last treatment session
measure: pain intensity
timeFrame: at follow-up visit 4 weeks after last treatment session
measure: swelling
timeFrame: at follow-up visit 4 weeks after last treatment session
measure: purpura
timeFrame: at follow-up visit 4 weeks after last treatment session
Secondary outcomes:
measure: patient satisfaction
timeFrame: at follow-up visit 4 weeks after last treatment session
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Laser Department, University Medical-Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: L Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: van Zuuren EJ. Rosacea. N Engl J Med. 2017 Nov 2;377(18):1754-1764. doi: 10.1056/NEJMcp1506630. No abstract available.
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.
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.
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.
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.
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.