moderate to severe Scalp Seborrheic Dermatitis MedDRA version: 9.1 Level: LLT Classification code 10039788 Term: Seborrheic dermatitis
Conditions
Interventions
Trade Name: Clobex ® 0.05 Shampoo
Product Name: Clobex
Pharmaceutical Form: Shampoo
INN or Proposed INN: clobetasol proprionate
Concentration unit: % (W/W) percent weight/weight
Concentration type: eq
Sponsors
Galderma Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female subjects aged 18 years or older, Subjects with moderate to severe scalp SD defined as: - a score = 3 on the Investigator’s Global Assessment scale - presence of Erythema, Scaling and Pruritus, each of at least moderate severity (severity score = 2), - at least 30% of the scalp area involved (Extend index =2) Female subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly effective method of contraception during the study: oral/systemic [injectable, patch…] contraception, intrauterine device, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy, Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, secondary infertility and sterility are not required to have a UPT at the beginning of the study, Subjects willing and capable of cooperating to the extend and degree required by the protocol, Subjects have to read and sign the approved Informed Consent Form prior to any participation in 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: Subjects with a known positive HIV or Hepatitis B/C test result, Subjects suffering from psoriasis, Subjects with a medical status requiring medication that might affect the course of the studied pathology (e.g. skin disease requiring a systemic corticosteroid or antifungal treatment) or interfere with study treatment, Subjects with a known allergy to one of the components of the test products, Subjects with an history of adverse response to topical or systemic steroid therapy, Female subjects who are pregnant, nursing or planning a pregnancy during the study, Subjects with a washout period for topical treatment(s) of their scalp SD less than: • Corticosteroids 2 weeks • All other anti-scalp SD medications (including, but not restricted to: anti-fungals (ketoconazole, ciclopirox olamine…), anti-dandruff products (tar, piroctonolamin, zinc pyritione, salicylic acid, selenium sulphur, keluamid, …) 2 weeks Subjects with a washout period for systemic treatment(s) less than: • Corticosteroids, anti-fungals - 4 Weeks • Immunosuppressive agents, PUVA/UVB therapy - 4 weeks • Retinoids and Depot corticosteroids 12 weeks Subjects with a condition or who is in a situation which, in the investigator’s opinion, may confound the study results, or may interfere significantly with the subject’s participation in the study, Adult subjects under guardianship, hospitalised subjects in a public or private institution for a reason other than the research, and subjects deprived of freedom, Subjects who have participated in another investigational drug or device research study within 30 days of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint will be the pourcentage change at week 4 in Total Severity Score (TSS) (sum of Erythema, scaling and pruritus.). ;Main Objective: The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in association with an antifungal shampoo (Ketoconazole 2%) in the treatment of moderate to severe scalp Seborrheic Dermatitis ;Secondary Objective: The safety and efficacy of Clobetasol propionate shampoo 0.05% alone compared to Ketoconazole shampoo 2% alone | — |
Countries
Belgium, Germany
Outcome results
None listed