The use of reflectance confocal microscopy for the monitoring of Demodex density and degree of inflammation in rosacea patients using topical Ivermectin 1% (Soolantra)
- Conditions
- rosacea10040790
- Registration Number
- NL-OMON45450
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
- 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)
- 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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Difference between the Demodex density before (t=0 weeks) and after (t=16<br /><br>weeks) treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Difference among the Demodex density before (t=0 weeks), during (t= 6, 12<br /><br>weeks) treatment and after follow up (t=28 weeks).<br /><br>2. Difference in the degree of inflammation before and after treatment.<br /><br>3. The difference in vascular diameter before and after treatment.<br /><br>4. The presence of parakeratosis, acanthosis and hyperkeratosis before and<br /><br>after treatment.</p><br>