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
- Conditions
- Topical treatment of moderate seborrheic dermatitis of the scalpMedDRA version: 9.1 Level: LLT Classification code 10039788 Term: Seborrheic dermatitis
- Registration Number
- EUCTR2008-008353-35-FR
- Lead Sponsor
- PIERRE FABRE DERMATOLOGIE REPRESENTED BY INSTITUT DE RECHERCHE PIERRE FABRE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 44
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
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.
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