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

Primary Purpose

Rosacea

Status
Not yet recruiting
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
KTP laser
Ivermectin 1% cream
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea focused on measuring Rosacea, Laser, Ivermectin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of dermatology, University Hospital Inselspital, Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser and cream

Laser alone

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Efficacy of laser and cream vs laser alone in reducing erythema as assessed by SRI
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.
Efficacy of laser and cream vs laser alone in reducing erythema as assessed by CEA
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.
Efficacy of laser and cream vs laser alone in the clinical improvement of skin lesions as assessed by PGA
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.
Patient's satisfaction related to laser and cream vs laser alone in the improvement of skin lesions as assessed by VAS
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.
Efficacy of laser and cream vs laser alone in reducing telangiectasia severity as assessed by TGS
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.
Efficacy of laser and cream vs laser alone in reducing papules and papulopustules
Any change in the number of papules and papulopustules on the side treated with KTP laser and ivermectin 1% cream vs laser alone.
Efficacy of laser and cream vs laser alone in reducing face swelling as assessed by the patient
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
Efficacy of laser and cream vs laser alone in reducing face redness as assessed by the patient
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.
Efficacy of laser and cream vs laser alone in reducing face purpura as assessed by the patient
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.

Full Information

First Posted
September 4, 2023
Last Updated
September 12, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT06033352
Brief Title
Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea
Acronym
KIR
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
Keywords
Rosacea, Laser, Ivermectin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
1:1 within-patient (split-face) random allocation
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser and cream
Arm Type
Experimental
Arm Title
Laser alone
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
KTP laser
Intervention Description
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
Drug
Intervention Name(s)
Ivermectin 1% cream
Intervention Description
Application of ivermectin 1% cream 1x/day. Interruption for 4 days in case of irritation/redness.
Primary Outcome Measure Information:
Title
Efficacy of laser and cream vs laser alone in reducing erythema as assessed by NEI
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Efficacy of laser and cream vs laser alone in reducing erythema as assessed by SRI
Description
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.
Time Frame
16 weeks
Title
Efficacy of laser and cream vs laser alone in reducing erythema as assessed by CEA
Description
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.
Time Frame
4, 8, 12, 16 weeks
Title
Efficacy of laser and cream vs laser alone in the clinical improvement of skin lesions as assessed by PGA
Description
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.
Time Frame
4, 8, 12, 16 weeks
Title
Patient's satisfaction related to laser and cream vs laser alone in the improvement of skin lesions as assessed by VAS
Description
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.
Time Frame
4, 8, 12, 16 weeks
Title
Efficacy of laser and cream vs laser alone in reducing telangiectasia severity as assessed by TGS
Description
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.
Time Frame
4, 8, 12, 16 weeks
Title
Efficacy of laser and cream vs laser alone in reducing papules and papulopustules
Description
Any change in the number of papules and papulopustules on the side treated with KTP laser and ivermectin 1% cream vs laser alone.
Time Frame
4, 8, 12, 16 weeks
Title
Efficacy of laser and cream vs laser alone in reducing face swelling as assessed by the patient
Description
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
Time Frame
4, 8, 12, 16 weeks
Title
Efficacy of laser and cream vs laser alone in reducing face redness as assessed by the patient
Description
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.
Time Frame
4, 8, 12, 16 weeks
Title
Efficacy of laser and cream vs laser alone in reducing face purpura as assessed by the patient
Description
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.
Time Frame
4, 8, 12, 16 weeks
Other Pre-specified Outcome Measures:
Title
Incidence of observed side-effects
Description
Cumulative number of observed treatment side-effects.
Time Frame
16 weeks
Title
Incidence of observed adverse events
Description
Cumulative number of observed treatment adverse events.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristine Heidemeyer, MD
Phone
316322218
Ext
+41
Email
Kristine.Heidemeyer@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Heidemeyer, MD
Organizational Affiliation
University Hospital Inselspital, Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of dermatology, University Hospital Inselspital, Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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