papulopustular rosacea
Conditions
Interventions
Product Name: Oxofulleram
Pharmaceutical Form: Cutaneous solution
Pharmaceutical form of the placebo: Cutaneous liquid
Route of administration of the placebo: Cutaneous use
Sponsors
Solenne BV
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: The difference of the Rosacea Clinical Score on the treated and placebo-treated face halves; 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: The difference of the Rosacea Clinical Score on the treated and placebo-treated face halves at week 2, 4, 6, 8, 10 en 12; 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Side effects ;Timepoint(s) of evaluation of this end point: Side effects at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12. | — |
Countries
Netherlands
Contacts
Public ContactClinical Trial Information
Solenne BV
Outcome results
None listed