Papulopustular Rosacea MedDRA version: 9.1 Level: LLT Classification code 10039218 Term: Rosacea
Conditions
Interventions
Trade Name: ROSICED 7.5 mg/g cream
Product Name: ROSICED
Product Code: DC034 CR
Pharmaceutical Form: Cream
INN or Proposed INN: METRONIDAZOLE
CAS Number: 443481
Concentration unit: mg/g milligram(s)/g
Sponsors
Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre
Eligibility
Sex/Gender
All
Inclusion criteria
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
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; . Hypersensitivity to 5-nitromidazole and/or alkyl-4-hydroxybenzoates (parabens) 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; · Patients with a known severe liver damage; · Patients with a known dyshematopoiesis; · Patients with a known disease of the central and/or peripheral nervous system; · Patients in an institution due to juridical or regulatory order. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the non-inferiority of a metronidazole 0.75% cream (Rosiced) in comparison to reference therapy (Rozex) in the local treatment of papulopustular rosacea;Secondary Objective: - To assess the superiority of Rosiced cream in comparison to its vehicle - To evaluate the safety of Rosicedâ cream in comparison to Rozex cream ;Primary end point(s): Improvement of inflammatory lesions (papules and pustules) count from D0 to wk12 (D84) and from D0 to wk6(D42). | — |
Countries
Austria, Estonia, France, Germany, Latvia, Sweden
Outcome results
None listed