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

INTERVENTION: Product Name: Oxofulleram Pharmaceutical Form: Cutaneous solution Pharmaceutical form of the placebo: Cutaneous liquid Route of administration of the placebo: Cutaneous use CONDITION: papulopustular rosacea Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: 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. 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. 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. 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 OUTCOME: 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. 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