Efficacy and safety of ASF-1075 cream 5% on pruritus in adult patients with atopic dermatitis. A multi-centre, randomised, double-blind, vehicle-controlled, parallel groups, proof of concept study.
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10012438Term: Dermatitis atopicCaucasian male and female patients 18-65 years of age with mild to moderate atopic dermatitis and experiencing moderate to severe pruritus.
- Registration Number
- EUCTR2007-003212-65-DK
- Lead Sponsor
- Astion Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Caucasian male and female patients 18-65 years of age with mild to moderate atopic dermatitis (AD) and experiencing moderate to severe pruritus defined as at least 30 mm using the VAS. In total 40 subjects (20 in each group) will be randomized.
A subject will be eligible for inclusion in this trial only if all of the following criteria apply:
•Caucasian male or female patient 18 to 65 years of age
•A clinical diagnosis of Atopic Dermatitis according to the criteria of Hanifin and Rajka7 and rated as mild to moderate with up to 15% involvement of total body area
•Intermittent pruritus
• Pruritus (overall pruritus over the last 24 hours) rated at the baseline visit as moderate intensity, i.e. at least 30 mm using the 100 mm VAS
•Females of childbearing potential should either be clinically sterile (postmenopausal 12 months, hysterectomy or tubal ligation) or use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with spermicide, intrauterine device (IUD), condom with intra-vaginal spermicide
•Willing and able to comply with the study procedures
•Signed informed consent according to ICH GCP and local regulation
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) no
F.1.3.1 Number of subjects for this age range
A subject will not be eligible for inclusion in this trial if any of the following criteria applies:
•Pregnant, breast feeding female or female planning to become pregnant during the study
•Impetiginised atopic dermatitis (AD)
•Active skin disease other than AD, which in the opinion of the investigator will interfere with evaluation of efficacy or safety or another progressive or serious disease that may interfere with the study outcome, specifically:
oActive skin disease other than AD e.g. seborrhoeic dermatitis, active infection, nummular eczema
oAny immunocompromised disease e.g. HIV
oSevere hepatic disease
oSevere renal disease
•Topical treatments of atopic dermatitis;
oCorticosteroids, immunomodulators (calcineurin inhibitors: pimecrolimus, tacrolimus), antihistamines, antibiotics or NSAIDs in the 2 weeks prior to the baseline visit.
oUV therapy during the last 4 weeks
• Systemic medications which may interfere with the evaluation of anti pruritic effect, or which may influence the severity of disease:
o Antibiotics, antihistamines, NSAIDs or aspirin in the 2 weeks prior to the baseline visit
oCorticosteroids (including inhalation), immunomodulators, immunosuppressants, cytostatics, retinoids, anti-malaria, anti psychotic triclyclic antidepreeants, or benzodiazepines during the last 4 weeks prior to the baseline visit.
•Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study
•Physical examination with disease findings considered, at the discretion of the investigator, to be relevant to the outcome of the study
•Known allergic reactions to components of the study preparations or to NSAIDs
•Must not be enrolled in another investigational drug study in the last 3 months prior to the baseline visit.
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