The use of reflectance confocal microscopy for the monitoring of Demodex density and degree of inflammation in rosacea patients using topical Ivermectin 1% (Soolantra)

The use of reflectance confocal microscopy for the monitoring of Demodex density and degree of inflammation in rosacea patients using topical Ivermectin 1% (Soolantra) - RCM in rosacea patients using Soolantra.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45450

Enrollment

Registered

2017-07-06

Start date

2018-02-19

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

rosacea

Interventions

Ivermectine 1% cream (Soolantra)

Reflectance confocal microscopy

Rosacea

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Healthy, male and non-pregnant female subjects, 16 years of age or older - Clinical diagnosis of papulopustular (PPR) or erythematoteleangiectatic (ETR) rosacea - Preference for treatment with topical Ivermectin 1% cream (within the standard care) above other rosacea treatments - Washout period of topical and systemic treatment for rosacea - In case of PPR subjects should have more than 15 papules or pustules and an Investigators Global Assessment (IGA) scale of > 3 (moderate) - In case of ETR subjects should have an erythema scale of > 3 (moderate) and teleangiectasia scale of >2 (moderate)

Exclusion criteria

Exclusion criteria: - Subjects with other facial dermatological condition or underlying disease, which requires the use of interfering topical or systemic therapy or may interfere with the rosacea diagnosis or its assessment - Preference of the patient to receive another rosacea treatment.

Design outcomes

Primary

Measure	Time frame
1. Difference between the Demodex density before (t=0 weeks) and after (t=16 weeks) treatment.	—

Secondary

Measure	Time frame
1. Difference among the Demodex density before (t=0 weeks), during (t= 6, 12 weeks) treatment and after follow up (t=28 weeks). 2. Difference in the degree of inflammation before and after treatment. 3. The difference in vascular diameter before and after treatment. 4. The presence of parakeratosis, acanthosis and hyperkeratosis before and after treatment.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)