Atopic Dermatitis MedDRA version: 9.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis
Conditions
Interventions
Trade Name: Betnovate Cream
Pharmaceutical Form: Cream
INN or Proposed INN: betamethasone-17-valerate
CAS Number: 2152-44-5
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Sponsors
Stiefel Laboratories
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects with mild-to-moderate AD based on Hanifin and Rajka diagnosis criteria and Rajka and Langeland grading system (score of 3 to 7.5). 2.An Investigator’s Global Assessment (IGA) score of 2 or 3. 3.Subjects of either sex aged 2 to 65 years. 4.Subjects who are willing and able to provide written informed consent. For subjects aged under 16 years of age, assent (where appropriate) and parental/guardian consent must be obtained. 5.Subjects (and/or parent/guardian) who agree to utilise subject diaries for the purposes of recording their (their childs) responses to questions regarding the signs and symptoms of their AD. 6.Subjects who are prepared to use the trial products and standardised washing regimen as instructed for the duration of the trial in place of their normal product and regimen. 7.Sexually active females of childbearing potential participating in the study must use a medically acceptable form of contraception (which includes oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A female of childbearing potential is defined as one who is biologically capable of becoming pregnant. Are the trial subjects under 18? yes 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Subjects with severe AD who require systemic or very-potent topical steroid treatment. 2.Subjects with facial AD. 3.Subjects with acutely infected AD, or areas where the lesions are crusted, weeping, or pustular. 4.Female subjects who are pregnant or lactating. 5.Subjects who are currently receiving or who have received during the 14 days before study entry, topical or systemic therapy likely to interfere with the study (e.g., antibiotic therapy, corticosteroids, anti-histamines, immunomodulators, anti-inflammatory agents). 6.Subjects who have participated, who are currently participating or who plan to participate in any other research study involving an investigational product or device at any time during and after the 4 weeks before study entry. 7.Subjects with any significant concurrent illness including psoriasis, rosacea, acne vulgaris, peri-oral dermatitis and primary skin lesions caused by infection with fungi or bacteria. 8.Subjects with a history of skin disease, other than AD, or allergy, likely to interfere with the study. 9.Subjects considered unable or unlikely to attend the necessary visits. 10.Employees or an immediate family member (partner, offspring, parents, siblings, or sibling’s offspring) of an employee of Euroderm Research or Stiefel Laboratories. 11.Subjects with past medical history of hepatic, renal, cardiac, pulmonary, digestive, hematological, neurological, locomotor, cancer or psychiatric disease, which, in the opinion of the Investigator would compromise the safety of the subject or affect the outcome of the study. 12.Subjects with known sensitivity to the test product ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Investigator’s Global Assessment (six-point scale) at visits 1 to 6 inclusive. Overall rating of response to study investigational product by Subject (five-point scale) at visits 4, 5 and 6. Change in the signs measured by SASSAD as determined by the Investigator’s SASSAD rating scale at weeks 4, 8 and 12 post-clearance as compared to baseline. ;Primary end point(s): Evaluation of the difference in time to the next AD flare (days) between the treatment groups.;Main Objective: Evaluate the Safety and Efficacy of medical device W0153 vs. standard moisturizer in maintaining clearance of symptoms in subjects with atopic dermatitis whose symptoms have previously cleared using a combined corticosteroid (Betnovate Cream) and moisturizer regimen | — |
Countries
United Kingdom
Outcome results
None listed