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

NCT ID: NCT06033352

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-12

Study Completion Date

2024-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Rosacea

Keywords

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Rosacea Laser Ivermectin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 within-patient (split-face) random allocation
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Laser and cream

Group Type EXPERIMENTAL

KTP laser

Intervention Type DEVICE

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.

Ivermectin 1% cream

Intervention Type DRUG

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

Laser alone

Group Type ACTIVE_COMPARATOR

KTP laser

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Ivermectin 1% cream

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Fitzpatrick skin type I-IV
* Presence of facial erythematous rosacea or mild papulopustular rosacea with permanent erythema
* Informed consent signed

Exclusion Criteria

* History of adverse events related to KTP laser therapy
* Pregnant or breastfeeding women
* Intention to become pregnant during the course of the study
* History of intolerance or allergic reaction to ivermectin 1% cream or one of the ingredients
* Ongoing treatment for skin cancer
* Ongoing treatment with strong inhibitors of P-glycoprotein (P-gp) and CYP3A4 (e.g., itraconazole, voriconazole, posaconazole, clarithromycin, cobicistat)
* Ongoing treatment with substances with a narrow therapeutic range whose excretion depends substantially on P-gp (e.g. digoxin, ciclosporin)
* Inability to understand the study content
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristine Heidemeyer, MD

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

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Department of dermatology, University Hospital Inselspital, Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2023-D0015

Identifier Type: -

Identifier Source: org_study_id