ON-INFERIORITY STUDY OF A METRONIDAZOLE 0.75% CREAM VERSUS REFERENCE THERAPY IN THE LOCAL TREATMENT OF PAPULOPUSTULAR ROSACEA.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

·Men or Women aged 18 years and over;
·Patients with papulopustular rosacea (stage II according to the ‘National Rosacea Society Expert Committee’ classification) requiring topical treatment alone;
·Patients with 8 to 30 inflammatory lesions (papules and pustules);
·Written informed consent obtained from the patient;
·If required by National regulations, patients must be registered with health social security or health insurance;
·Patients willing to attend the planned study visits at the investigational centre and to comply with all trial requirements.

For women of childbearing potential:
·Urine pregnancy test negative at inclusion;
·Use of efficient method of contraception (oral contraception, intra-uterine device, tubal ligature) for at least 2 months before inclusion, during all the study and until 1 month after the end of the study.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Related to the pathology:
·Other types of rosacea;
·Skin diseases or underlying conditions that may interfere with the rosacea evaluation or require topical and/or systemic treatments.

Related to rosacea treatment:
·Topical treatment of rosacea (e.g. azelaic acid, benzoyl peroxide, metronidazole) within 4 weeks before the inclusion visit;
·Systemic treatment of rosacea (e.g. cyclins) within 4 weeks before the inclusion visit;
·Cosmetic management of rosacea within 2 weeks before the inclusion visit;
·Laser therapy of rosacea within 2 weeks before the inclusion visit.

Related to other treatments:
·Topical treatment (e.g. retinoids, antibiotics, steroids, azelaic acid, topical calcineurin inhibitors) of the face within 2 weeks before the inclusion visit;
·Systemic steroids and/or antibiotics (e.g. cyclins, macrolids, metronidazole) within 4 weeks before the inclusion visit;
·Oral Isotretinoin within 3 months before the inclusion visit.
·Oral ivermectin within 3 months before the inclusion visit.

Related to patient :
·Known sensitivity to any of study drug ingredient(s);
·History of major medical/psychiatric illness or surgery which, in the judgment of the investigator, may interfere with study implementation and/or study parameter assessment(s);
·Patients who are not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent;
·Patients who have forfeited their freedom by administrative or legal decision or who are under guardianship;
·According to National regulations, patients hospitalised in a medical or a social center for another reason than biomedical research.

For women of childbearing potential:
·Women who are pregnant or planning a pregnancy during the course of study;
·Women not using effective contraception;
·Breast-feeding women.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method