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Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea

NCT06033352 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-12-06

No results posted yet for this study

Summary

Rosacea is a frequent chronic inflammatory disease affecting mainly the face but also eyes and scalp. Rosacea is classified into 3 types: erythemato-teleangiectatica, papulopustulosa and phymatosa. Treatments depend on the type and include topical and systemic antibiotics, azelaic acid, topical ivermectin, topical brimonidine, systemic isotretinoin as well as intense pulsed light (IPL) and laser therapies.

For treatment of telangiectasia and redness, laser and IPL therapies are the first choice. Vascular lasers, such as pulsed dye lasers (PDL) and potassium-titanyl phosphate (KTP) lasers as well as IPL, have demonstrated good efficacy in reduction of erythema and telangiectasias in patients with rosacea. However, these treatments are expensive and mostly not covered by the health insurance. Therefore, for patients it is important to receive the maximal effect and improvement after each single laser session.

Ivermectin is a semi-synthetic derivative of avermectin and has an anti-inflammatory effect as well as an antiparasitic effect on demodex mite. The latter is playing an important pathogenetic role in rosacea.

This randomized controlled study aims to compare the effect of KTP laser in combination with ivermectin 1% cream vs KTP laser alone in patients with facial rosacea.

Conditions

  • Rosacea

Interventions

DEVICE

KTP laser

Treatment with KTP 532 nm laser. Laser fluence depends on erythema intensity and ranges from 7.0 J/cm2 to 11 J/cm2 with a 4-11 mm spot size and 8-12 ms pulse duration.

DRUG

Ivermectin 1% cream

Application of ivermectin 1% cream 1x/day. Interruption for 4 days in case of irritation/redness.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Kristine Heidemeyer, MD · Insel Gruppe AG, University Hospital Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2024-11-01
Completion
2024-11-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06033352 on ClinicalTrials.gov