The treatment of Rosacea with Oxofulleram. A pilot study to assess the clinical applicability of Oxofulleram

Conditions: papulopustular rosacea
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2014-004962-76-NL

Lead Sponsor: Solenne BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to investigate whether there is an objective established left-right difference detectable in patients with papulopustular rosacea when Oxofulleram is applied twice a day topically unilaterally in the face.;Secondary Objective: Are then any side effects detectable when in patients with papulopustular rosacea when Oxofulleram is applied twice a day topically unilaterally in the face.;Primary end point(s): Primary endpoint:<br>The difference of the Rosacea Clinical Score on the treated and placebo-treated face halves;<br>The difference of the Patient Self-evaluation on the treated and placebo-treated face halves.;Timepoint(s) of evaluation of this end point: Primary endpoint:<br>The difference of the Rosacea Clinical Score on the treated and placebo-treated face halves at week 2, 4, 6, 8, 10 en 12;<br>The difference of the Patient Self-evaluation on the treated and placebo-treated face halves at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 en 12.

Secondary Outcome Measures