CClinicalTrials.gg
Status unknownNCT02036229Updated Jan 13, 2015

Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis

A Phase 3 interventional study of ivermectin cream 0.5% in Demodicidosis and Rosacea, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-13.

Sponsored by Rabin Medical Center · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether 0.5% ivermectin cream is effective in the treatment of demodicidosis (including papulopustular rosacea)

02

Conditions studied

  • Demodicidosis
  • Rosacea

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Keywords

  • demodex
  • demodicidosis
  • rosacea
  • ivermectin
03

In context

Rosacea

225 studies on the registry are indexed under Rosacea; 19 are open to participants now.

This study's planned enrollment of 50 is below the median of 61 across 195 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • subjects with clinical and laboratory diagnosis of demodicidosis with symmetrical facial eruption who are willing to comply with study requirements

Exclusion criteria

Exclusion Criteria:

  • known hypersensitivity to ivermectin.
  • pregnancy
  • immunodeficiency such as HIV or immunosuppressive therapy
  • concomitant use of systemic antibiotics or steroids
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    0.5% ivermectin cream

    Each participant will be treated with topical ivermectin cream 0.5% qd for one half of the face for 1 month. In the second month all patients will be treated with ivermectin cream for the entire skin involvement.

    Drug: ivermectin cream 0.5%

  • Placebo comparator
    vehicle cream

    Each participant will be treated with a vehicle cream qd for the other half of the face for 1 month. In the second month all patients will be treated with ivermectin cream for the entire skin involvement.

    Drug: ivermectin cream 0.5%

Interventions

  • Drugivermectin cream 0.5%

    Each participant will be treated with topical ivermectin cream 0.5% qd for one half of the face and with a vehicle cream qd for the other half of the face for 1 month. In the second month all patients will be treated with ivermectin cream for the entire skin involvement.

06

What researchers measure

Primary outcomes

  1. A decrease in mite density in skin surface biopsy after treatment with topical ivermectin (≤5 mites/cm2 for skin lesions).

    Time frame: 5 months

Secondary outcomes

  1. Clinical improvement

    Clinical improvement will be assessed by objective evaluation of erythema, dryness, scaling, roughness, and/or papules/pustules in skin lesions and subjective evaluation of itch and dryness.

    Time frame: 5 months

  2. A comparable dermoscopic improvement in the demodicidosis features

    dermoscopic demodicidosis features: * number of demodex tails * demodex follicular openings * reticular dilated vessels.

    Time frame: 5 months

07

Study locations

1 of 1 sites recruiting
  • RabinMC, Dermatology dept.
    Petah-Tiqva, Israel
    • Rina Segal, MD · Contact · 972505206134
    • Rina Segal, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02036229
Lead sponsor
Rabin Medical Center
Responsible party
Rina Segal (MD, Rabin Medical Center) — Principal investigator
First posted
Jan 14, 2014
Start date
Feb 2014
Primary completion
Dec 2015 (estimated)
Completion
Jun 2016 (estimated)
Last update
Jan 13, 2015

Study contacts

Rina Segal, MD
Contact
rinas3@clalit.org.il
972505206134
Rina Segal, MD
principal investigator · Rabin Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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