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

NCT ID: NCT05771298

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-06-01

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.

Conditions

Rosacea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Potassium Titanyle Phosphate (KTP) Laser

Subjects will be treated with a KTP laser in 1 - 3 sessions at intervals of 4 - 6 weeks.

Group Type: OTHER

532nm KTP

Intervention Type: DEVICE

one to three treatment sessions

Pulsed Dye Laser

Subjects will be treated with a PDL in 1 - 3 sessions at intervals of 4 - 6 weeks.

Group Type: OTHER

585nm PDL

Intervention Type: DEVICE

one to three treatment sessions

Interventions

532nm KTP

one to three treatment sessions

Intervention Type: DEVICE

585nm PDL

one to three treatment sessions

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

L Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

Laser Department, University Medical-Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

L Nguyen, MD

Role: CONTACT

l.nguyen@uke.de

+49 (0)40 7410-0

Facility Contacts

L Nguyen, MD

Role: primary

040 7410 0

References

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.

Reference Type: BACKGROUND

PMID: 25919144 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 29091565 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24229634 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20586834 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30285506 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32141785 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29635699 (View on PubMed)

Nguyen L, Seeber N, Kautz G, Hartjen A, Schneider SW, Herberger K. 532-nm potassium titanyl-phosphate laser versus 595-nm pulsed dye laser for port-wine birthmarks: A prospective, randomized, split-side study. J Eur Acad Dermatol Venereol. 2024 Jun;38(6):1140-1146. doi: 10.1111/jdv.19750. Epub 2023 Dec 21.

Reference Type: DERIVED

PMID: 38794945 (View on PubMed)

Other Identifiers

01-22

Identifier Type: -

Identifier Source: org_study_id