Efficacy and Safety of Clobetasol propionate shampoo 0.05% used in association with an antifungal shampoo in the treatment of moderate to severe Scalp Seborrheic Dermatitis - ESCAPE - Scalp Seborrheic Dermatitis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 320

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

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:
•Corticosteroids2 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 corticosteroids12 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.

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

Related Trials