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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. |
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Register:
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EUCTR |
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Last refreshed on:
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10 December 2019 |
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Main ID: |
EUCTR2008-008353-35-FR |
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Date of registration:
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17/03/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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EFFICACY STUDY OF A CICLOPIROXOLAMINE 1% FOAM (DC115 GM 02A) VERSUS CICLOPIROXOLAMINE 1.5% SHAMPOO (SEBIPROX®) IN THE TREATMENT OF MODERATE SEBORRHEIC DERMATITIS OF THE SCALP
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Scientific title:
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EFFICACY STUDY OF A CICLOPIROXOLAMINE 1% FOAM (DC115 GM 02A) VERSUS CICLOPIROXOLAMINE 1.5% SHAMPOO (SEBIPROX®) IN THE TREATMENT OF MODERATE SEBORRHEIC DERMATITIS OF THE SCALP |
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Date of first enrolment:
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18/03/2009 |
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Target sample size:
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44 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-008353-35 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: yes
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: intraindividual comparison, investigator masked
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients must meet all the following criteria to enter the study:
- Patients aged more than 18 years old,- Stable or exacerbating seborrheic dermatitis of the scalp as evidenced by a score of scaling and erythema between 2 to 4,
- Comparable intensity of seborrheic dermatitis on both sides of the half head,
- Patients who agree to stop application of any topical product (drugs and/or cosmetics) on the scalp and use only the delivered soft shampoo during the study period,
- Written Informed Consent Form obtained from the patient,
- Patient willing to attend the planned all visits at the investigational centre and to comply with all trial requirements,
- Patient registered with a social security,
- For woman of childbearing potential:
? negative urine pregnancy test at inclusion,
? use an efficient method of contraception (implants, injectables, oral contraceptives, intra-uterine devices, tubal ligature) for at least 2 months before the study, during and one 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:
Patients who have one of the following criteria will not be allowed to enter the study:
* Related to the pathologies
- Severe seborrheic dermatitis requiring a treatment with corticosteroids,
- Psoriasis of any type and anywhere on the body,
- Asthma requiring regular treatment with corticosteroids (inhaled, oral or injectable),
- History and/or current disease of immunosuppression,
- Parkinson disease,
- History of a major medical/psychiatric illness or surgery which, in the judgement of the investigator, may interfere with study medication, metabolism and/or study implementation and/or study parameter assessment(s).
*Related to treatments
- Patients with a history of hypersensitivity to ciclopiroxolamine and/or to at least one ingredient of the products,
- Treatment with any other investigational product in the 4 weeks prior to the inclusion visit,
- Topical treatment of the scalp with other antifungal medication, retinoids, erythromycin, tetracycline or any of its derivates, trimethoprim/sulfamethoxazole, metronidazole, or corticosteroids within the 2 weeks prior the inclusion visit,
- Systemic use of retinoids, erythromycin, tetracycline or any of its derivates, trimethoprim/sulfamethoxazole, or metronidazole within the 4 weeks prior to the inclusion visit,
- Systemic use of corticosteroids within the 12 weeks prior to the inclusion visit,
* Related to the population
- Sensitive skin to topical or cosmetic products,
- History of drug or alcohol abuse,
- Female who is pregnant or breast feeding or not using contraception, or planning to become pregnant,
- Participation to an other clinical trial in the previous month or during the study,
- Patient who, is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent,
- Patient who, in the judgement of the investigator, is not likely to be compliant during the study,
- Patient who has forfeited his/her freedom by administrative or legal decision, or who is under guardianship.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Topical treatment of moderate seborrheic dermatitis of the scalp
MedDRA version: 9.1
Level: LLT
Classification code 10039788
Term: Seborrheic dermatitis
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Intervention(s)
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Product Code: DC115GM02A
Pharmaceutical Form: Cutaneous foam
INN or Proposed INN: CICLOPIROX OLAMINE
CAS Number: 41621492
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 1-
Trade Name: SEBIPROX
Product Name: SEBIPROX
Pharmaceutical Form: Shampoo
INN or Proposed INN: CICLOPIROX OLAMINE
CAS Number: 41621492
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 1.5-
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Primary Outcome(s)
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Secondary Objective: ? To assess the efficacy of a ciclopiroxolamine 1% foam (DC115 GM 02A), on moderate of seborrheic dermatitis of the scalp, after 2 weeks treatment,
? To assess the local and general tolerance of DC115 GM 02A foam, after 4 weeks treatment.
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Main Objective: To assess the efficacy of a ciclopiroxolamine 1% foam (DC115 GM 02A) versus reference therapy ciclopiroxolamine 1.5% shampoo (SEBIPROX®), on moderate seborrheic dermatitis of the scalp, after 4 weeks treatment.
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Primary end point(s): Treatment effectiveness:The primary end-point will be the sum score of seborrheic dermatitis, at day 28. The sum score is defined as the sum of clinical symptoms of scaling and erythema.
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Secondary ID(s)
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DC0115GM2012A
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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