Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Study

Rosacea Clinical Trial

Official title:

Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Case-Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05771298
• Other study ID #: 01-22
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: L Nguyen, MD
• Phone: +49 (0)40 7410-0
• Email: l.nguyen[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy and safety of 532 nm KTP and 585 nm PDL for treating rosacea.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rosacea

Intervention

Device:
• 532nm KTP
one to three treatment sessions
• 585nm PDL
one to three treatment sessions

Locations

Country	Name	City	State
Germany	Laser Department, University Medical-Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

van Zuuren EJ. Rosacea. N Engl J Med. 2017 Nov 2;377(18):1754-1764. doi: 10.1056/NEJMcp1506630. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of erythema	assessment scale 0 - 4 (normal skin - severe erythema) evaluated by physician and blinded investigator	at follow-up visit 4 weeks after last treatment session
Primary	pain intensity	using numeric rating scale 0 - 10 (none - unbearable pain) evaluated by subjects	at follow-up visit 4 weeks after last treatment session
Primary	swelling	assessment scale 1 - 6 (very - none) evaluated by subjects	at follow-up visit 4 weeks after last treatment session
Primary	purpura	assessment scale 1 - 6 (very - none) evaluated by subjects	at follow-up visit 4 weeks after last treatment session
Secondary	patient satisfaction	assessment scale 1 - 6 (very - not at all) evaluated by subjects	at follow-up visit 4 weeks after last treatment session