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

NCT05771298 | Unknown

• 1 other identifier: 01-22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rosacea

Outcome Measures

Primary Outcomes (4)

• 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

• pain intensity

  using numeric rating scale 0 - 10 (none - unbearable pain) evaluated by subjects

  at follow-up visit 4 weeks after last treatment session

• swelling

  assessment scale 1 - 6 (very - none) evaluated by subjects

  at follow-up visit 4 weeks after last treatment session

• purpura

  assessment scale 1 - 6 (very - none) evaluated by subjects

  at follow-up visit 4 weeks after last treatment session

Secondary Outcomes (1)

• patient satisfaction

  at follow-up visit 4 weeks after last treatment session

Study Arms (2)

Potassium Titanyle Phosphate (KTP) Laser

OTHER

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

Device: 532nm KTP

Pulsed Dye Laser

OTHER

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

Device: 585nm PDL

Interventions

532nm KTP DEVICE

one to three treatment sessions

Potassium Titanyle Phosphate (KTP) Laser

585nm PDL DEVICE

one to three treatment sessions

Pulsed Dye Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Laser Department, University Medical-Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related Publications (8)

• 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.

  PMID: 25919144 BACKGROUND

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

  PMID: 29091565 BACKGROUND

• 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.

  PMID: 24229634 BACKGROUND

• 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.

  PMID: 20586834 BACKGROUND

• 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.

  PMID: 30285506 BACKGROUND

• 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.

  PMID: 32141785 BACKGROUND

• 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.

  PMID: 29635699 BACKGROUND

• 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.

  PMID: 38794945 DERIVED

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• L Nguyen, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

L Nguyen, MD

CONTACT

+49 (0)40 7410-0; l.nguyen@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 16, 2023
• Study Start: February 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)