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NCT Number: NCT06033352

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

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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of dermatology, University Hospital Inselspital, Bern

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KTP laser

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

Drug

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

Primary outcomes

  1. Efficacy of laser and cream vs laser alone in reducing erythema as assessed by NEI

    Time frame: 16 weeks

    Any relative decrease of erythema on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by Normalized Erythema Index (NEI), ranging from 0 to 80, with higher values indicating a worst erythema.

Secondary outcomes

  1. Efficacy of laser and cream vs laser alone in reducing erythema as assessed by SRI

    Time frame: 16 weeks

    Any relative decrease of erythema on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by Skin Redness Index (SRI), ranging from 1 to 4, with higher score indicating a worst erythema.

  2. Efficacy of laser and cream vs laser alone in reducing erythema as assessed by CEA

    Time frame: 4, 8, 12, 16 weeks

    Any decrease of erythema on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by Clinical Erythema Assessment (CEA), ranging from 0 to 4, with higher score indicating a worst erythema.

  3. Efficacy of laser and cream vs laser alone in the clinical improvement of skin lesions as assessed by PGA

    Time frame: 4, 8, 12, 16 weeks

    Any change of skin lesions on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by 6-point Physician Global Assessment (PGA), ranging from 0 to 5, with higher score indicating a better outcome.

  4. Patient's satisfaction related to laser and cream vs laser alone in the improvement of skin lesions as assessed by VAS

    Time frame: 4, 8, 12, 16 weeks

    Any difference of patient's satisfaction for the improvement of skin lesions on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by a 9-point anchored visual analogue scale (VAS), ranging from -4 to +4, with negative scores indicating a worsening of condition, with 0 indicating no difference and with positive scores indicating an improvement.

  5. Efficacy of laser and cream vs laser alone in reducing telangiectasia severity as assessed by TGS

    Time frame: 4, 8, 12, 16 weeks

    Any change of telangiectasia severity on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by telangiectasia grading scale (TGS), ranging from 0 to 3, with higher score indicating a worst telangiectasia severity.

  6. Efficacy of laser and cream vs laser alone in reducing papules and papulopustules

    Time frame: 4, 8, 12, 16 weeks

    Any change in the number of papules and papulopustules on the side treated with KTP laser and ivermectin 1% cream vs laser alone.

  7. Efficacy of laser and cream vs laser alone in reducing face swelling as assessed by the patient

    Time frame: 4, 8, 12, 16 weeks

    Any change in the number of days of face swelling on the side treated with KTP laser and ivermectin 1% cream vs laser alone, as assessed by the patient

  8. Efficacy of laser and cream vs laser alone in reducing face redness as assessed by the patient

    Time frame: 4, 8, 12, 16 weeks

    Any change in the number of days of face redness on the side treated with KTP laser and ivermectin 1% cream vs laser alone, as assessed by the patient.

  9. Efficacy of laser and cream vs laser alone in reducing face purpura as assessed by the patient

    Time frame: 4, 8, 12, 16 weeks

    Any change in the number of days of face purpura on the side treated with KTP laser and ivermectin 1% cream vs laser alone, as assessed by the patient.

Other outcomes

  1. Incidence of observed side-effects

    Time frame: 16 weeks

    Cumulative number of observed treatment side-effects.

  2. Incidence of observed adverse events

    Time frame: 16 weeks

    Cumulative number of observed treatment adverse events.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study 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

Acronym: KIR

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 13, 2023
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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