Topical treatment of moderate seborrheic dermatitis of the scalp MedDRA version: 9.1 Level: LLT Classification code 10039788 Term: Seborrheic dermatitis
Conditions
Interventions
Product Code: DC115GM02A
Pharmaceutical Form: Cutaneous foam
INN or Proposed INN: CICLOPIROX OLAMINE
CAS Number: 41621492
Concentration
Sponsors
PIERRE FABRE DERMATOLOGIE REPRESENTED BY INSTITUT DE RECHERCHE PIERRE FABRE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.; 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. ;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. | — |
Countries
France
Outcome results
None listed