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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2006-007029-29-FR |
Date of registration:
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26/03/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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NON-INFERIORITY STUDY OF A METRONIDAZOLE 0.75% CREAM VERSUS REFERENCE THERAPY IN THE LOCAL TREATMENT OF PAPULOPUSTULAR ROSACEA.
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Scientific title:
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NON-INFERIORITY STUDY OF A METRONIDAZOLE 0.75% CREAM VERSUS REFERENCE THERAPY IN THE LOCAL TREATMENT OF PAPULOPUSTULAR ROSACEA. |
Date of first enrolment:
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05/04/2007 |
Target sample size:
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300 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-007029-29 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Estonia
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France
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Germany
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Latvia
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Sweden
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Key inclusion & exclusion criteria
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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) no 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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Papulopustular Rosacea
MedDRA version: 9.1
Level: LLT
Classification code 10039218
Term: Rosacea
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Intervention(s)
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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-
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Primary Outcome(s)
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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
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Primary end point(s): Improvement of inflammatory lesions (papules and pustules) count from D0 to wk12 (D84) and from D0 to wk6(D42).
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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
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Secondary ID(s)
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DC0034 CR 301
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2006-007029-29-EE
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
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