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

Insel Gruppe AG, University Hospital Bern

Status and phase

Completed

Phase 2

Conditions

Rosacea

Treatments

Drug: Ivermectin 1% cream

Device: KTP laser

Study type

Interventional

Funder types

Other

Identifiers

NCT06033352

2023-D0015

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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