Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis

a Randomised, Double Blind, Placebo Controlled, Half- Face Study to Evaluate the Effect of Topical Ivermectin Cream 0.5% on Demodicidosis

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02036229

Enrollment

Registered

2014-01-14

Start date

2014-02-28

Completion date

2016-06-30

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Demodicidosis, Rosacea

Keywords

demodex, demodicidosis, rosacea, ivermectin

Brief summary

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

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Clinical improvement	5 months	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.
A comparable dermoscopic improvement in the demodicidosis features	5 months	dermoscopic demodicidosis features: * number of demodex tails * demodex follicular openings * reticular dilated vessels.

Countries

Israel

Contacts

Primary ContactRina Segal, MD

rinas3@clalit.org.il972505206134

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026