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

March 5, 2023 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • Laser Department, University Medical-Center Hamburg-Eppendorf
        • Contact:
          • L Nguyen, MD
          • Phone Number: 040 7410 0

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Potassium Titanyle Phosphate (KTP) Laser
Subjects will be treated with a KTP laser in 1 - 3 sessions at intervals of 4 - 6 weeks.
Device: 532nm KTP
one to three treatment sessions
Other: Pulsed Dye Laser
Subjects will be treated with a PDL in 1 - 3 sessions at intervals of 4 - 6 weeks.
Device: 585nm PDL
one to three treatment sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of erythema
Time Frame: at follow-up visit 4 weeks after last treatment session
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
Time Frame: at follow-up visit 4 weeks after last treatment session
using numeric rating scale 0 - 10 (none - unbearable pain) evaluated by subjects
at follow-up visit 4 weeks after last treatment session
swelling
Time Frame: at follow-up visit 4 weeks after last treatment session
assessment scale 1 - 6 (very - none) evaluated by subjects
at follow-up visit 4 weeks after last treatment session
purpura
Time Frame: at follow-up visit 4 weeks after last treatment session
assessment scale 1 - 6 (very - none) evaluated by subjects
at follow-up visit 4 weeks after last treatment session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction
Time Frame: at follow-up visit 4 weeks after last treatment session
assessment scale 1 - 6 (very - not at all) evaluated by subjects
at follow-up visit 4 weeks after last treatment session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: L Nguyen, MD, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 5, 2023

First Submitted That Met QC Criteria

March 5, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 5, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rosacea

Clinical Trials on 532nm KTP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe