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AzTrials

RosaceaPhase 2KIRNCT06033352

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

A Phase 2 study testing KTP laser and Ivermectin 1% cream in people with Rosacea, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rosacea
What is being tested?
KTP laser and Ivermectin 1% cream
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteSwitzerland
Study dates
12 Sep 2023to 1 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of dermatology, University Hospital Inselspital, Bern

    Bern, 3010

Other trials in Switzerland

About this study

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

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.

Read more

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
Being tested
KTP laser, Ivermectin 1% cream
Keywords
Rosacea, Laser, Ivermectin
Medical subject headings
Rosacea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KTP laserDevice

    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% creamDrug

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

Study groups in NCT06033352
Study groupRoleWhat they receive
Laser and creamExperimentalNot described
Receives: Device: KTP laser; Drug: Ivermectin 1% cream
Laser aloneActive comparatorNot described
Receives: Device: KTP laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16 weeks

Secondary outcomes (9)

  1. 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.

    Measured: 16 weeks

  2. 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.

    Measured: 4, 8, 12, 16 weeks

  3. 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.

    Measured: 4, 8, 12, 16 weeks

  4. 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.

    Measured: 4, 8, 12, 16 weeks

  5. 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.

    Measured: 4, 8, 12, 16 weeks

  6. 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.

    Measured: 4, 8, 12, 16 weeks

  7. 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

    Measured: 4, 8, 12, 16 weeks

  8. 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.

    Measured: 4, 8, 12, 16 weeks

  9. 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.

    Measured: 4, 8, 12, 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start12 Sep 2023
  3. Primary completion1 Nov 2024
  4. Study completion1 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 within-patient (split-face) random allocation
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06033352
Sponsor's protocol ID
2023-D0015
Acronym
KIR
Status last verified
Dec 2024
First submitted
4 Sep 2023
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Heidemeyer K, Cazzaniga S, Junge A, Lehmann M, Seyed Jafari SM, Yawalkar N, Feldmeyer L, Bossart S. Treatment of redness in rosacea with potassium-titanyl-phosphate (KTP) 532 nm laser with and without topical 1% ivermectin cream: a randomized split-face trial. J Dermatolog Treat. 2026 Dec;37(1):2635882. doi: 10.1080/09546634.2026.2635882. Epub 2026 Mar 4.

    PubMed 41778357

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KTP laser and Ivermectin 1% cream in people with Rosacea, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of laser and cream vs laser alone in reducing erythema as assessed by NEI (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06033352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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