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

NCT06033352 | Completed Phase 2

• 1 other identifier: 2023-D0015
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea

Keywords

Rosacea; Laser; Ivermectin

Outcome Measures

Primary Outcomes (1)

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

  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.

  16 weeks

Secondary Outcomes (9)

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

  16 weeks

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

  4, 8, 12, 16 weeks

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

  4, 8, 12, 16 weeks

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

  4, 8, 12, 16 weeks

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

  4, 8, 12, 16 weeks

Other Outcomes (2)

• Incidence of observed side-effects

  16 weeks

• Incidence of observed adverse events

  16 weeks

Study Arms (2)

Laser and cream

EXPERIMENTAL

Device: KTP laser; Drug: Ivermectin 1% cream

Laser alone

ACTIVE COMPARATOR

Device: KTP laser

Interventions

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.

Laser alone; Laser and cream

Ivermectin 1% cream DRUG

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

Laser and cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of dermatology, University Hospital Inselspital, Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Rosacea

Interventions

Lasers, Solid-State; Ivermectin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Kristine Heidemeyer, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 within-patient (split-face) random allocation

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 13, 2023
• Study Start: September 12, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)