Clinical trial NCT06033352: Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea
Official title: Comparison of the Efficacy of Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser Combined With Ivermectin 1% Cream for Facial Rosacea: a Randomized Split-face Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rosacea
Keywords: Rosacea
Laser
Ivermectin
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 within-patient (split-face) random allocation
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of laser and cream vs laser alone in reducing erythema as assessed by NEI
timeFrame: 16 weeks
Secondary outcomes:
measure: Efficacy of laser and cream vs laser alone in reducing erythema as assessed by SRI
timeFrame: 16 weeks
measure: Efficacy of laser and cream vs laser alone in reducing erythema as assessed by CEA
timeFrame: 4, 8, 12, 16 weeks
measure: Efficacy of laser and cream vs laser alone in the clinical improvement of skin lesions as assessed by PGA
timeFrame: 4, 8, 12, 16 weeks
measure: Patient's satisfaction related to laser and cream vs laser alone in the improvement of skin lesions as assessed by VAS
timeFrame: 4, 8, 12, 16 weeks
measure: Efficacy of laser and cream vs laser alone in reducing telangiectasia severity as assessed by TGS
timeFrame: 4, 8, 12, 16 weeks
measure: Efficacy of laser and cream vs laser alone in reducing papules and papulopustules
timeFrame: 4, 8, 12, 16 weeks
measure: Efficacy of laser and cream vs laser alone in reducing face swelling as assessed by the patient
timeFrame: 4, 8, 12, 16 weeks
measure: Efficacy of laser and cream vs laser alone in reducing face redness as assessed by the patient
timeFrame: 4, 8, 12, 16 weeks
measure: Efficacy of laser and cream vs laser alone in reducing face purpura as assessed by the patient
timeFrame: 4, 8, 12, 16 weeks
Other outcomes:
measure: Incidence of observed side-effects
timeFrame: 16 weeks
measure: Incidence of observed adverse events
timeFrame: 16 weeks
Locations:
city: Bern
country: Switzerland
facility: Department of dermatology, University Hospital Inselspital, Bern
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Kristine Heidemeyer, MD
role: PRINCIPAL_INVESTIGATOR
References: