De behandeling van Rosacea met Oxofulleram. Een pilotonderzoek naar de klinische toepasbaarheid van Oxofulleram.

Phase 2

Completed

• Conditions: Rosacea; 10014982; Papulopustular Rosacea

• Registration Number: NL-OMON53162
• Lead Sponsor: Solenne BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- a diagnosis of papulopustular rosacea;
- the conventional treatments of rosacea should be stopped with a wash-out period of one month;
- age 18-65 years;
- male and female;
- women of childbearing age use double barrier contraception

Exclusion Criteria

- Patients with non papulopustular subtypes of rosacea are excluded from the study;
- Patients with other facial dermatoses (acne, perioral dermatitis, eczema);
- Age: younger than 18 and older than 65 years;
- Pregnancy;
- Patients treated with an EGFR inhibitor for an oncological condition are excluded from the study;
- Legally incapable.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>- the difference in the clinical scores of rosacea of the treated and the<br /><br>placebo-treated<br /><br>sides of the face on weeks 2, 4, 6, 8, 10 and 12.<br /><br>- The difference in the rosacea patients self-evaluation scores of the treated<br /><br>and the placebo-treated sides of the face on weeks 1, 2, 3, 4, 5, 6, 7, 8, 9,<br /><br>10, 11 and 12.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Side effects</p><br>