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

• Register: EUCTR
• Last refreshed on: 10 December 2012
• Main ID: EUCTR2006-007029-29-DE
• Date of registration: 24/07/2007
• Prospective Registration: Yes
• Primary sponsor: Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre
• Public title: NON-INFERIORITY STUDY OF A METRONIDAZOLE 0.75% CREAM VERSUS REFERENCE THERAPY IN THE LOCAL TREATMENT OF PAPULOPUSTULAR ROSACEA.
• Scientific title: NON-INFERIORITY STUDY OF A METRONIDAZOLE 0.75% CREAM VERSUS REFERENCE THERAPY IN THE LOCAL TREATMENT OF PAPULOPUSTULAR ROSACEA.
• Date of first enrolment: 06/11/2007
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-007029-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Austria, Estonia, France, Germany, Latvia, Sweden

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Papulopustular Rosacea
MedDRA version: 9.1 Level: LLT Classification code 10039218 Term: Rosacea

Intervention(s)

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)/gram
Concentration type: equal
Concentration number: 7.5-
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Cutaneous use

Trade Name: ROZEX 0.75% cream
Product Name: ROZEX
Pharmaceutical Form: Cream
INN or Proposed INN: METRONIDAZOLE
CAS Number: 443481
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 7.5-

Primary Outcome(s)

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).

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 ID(s)

2006-007029-29-EE

DC0034 CR 301