Caucasian male and female patients 18-65 years of age with mild to moderate atopic dermatitis and experiencing moderate to severe pruritus. MedDRA version: 9.1 Level: LLT Classification code 10012438 Term: Dermatitis atopic
Conditions
Interventions
Product Name: ASF-1075 Cream 5%
Pharmaceutical Form: Cream
Current Sponsor code: ASF-1075
Other descriptive name: monoethanolamine salt of oxaprozine
Concentration unit: % (W/W) percent weight/weight
Sponsors
Astion Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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: o Active skin disease other than AD e.g. seborrhoeic dermatitis, active infection, nummular eczema o Any immunocompromised disease e.g. HIV o Severe hepatic disease o Severe renal disease • Topical treatments of atopic dermatitis; o Corticosteroids, immunomodulators (calcineurin inhibitors: pimecrolimus, tacrolimus), antihistamines, antibiotics or NSAIDs in the 2 weeks prior to the baseline visit. o UV 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 o Corticosteroids (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the treatment effect of ASF-1075 cream 5% on pruritus in adult patients with mild to moderate atopic dermatitis following 3 weeks randomised double blind vehicle controlled treatment with up to maximum 5 times daily application. ;Secondary Objective: The secondary objectives are: •To investigate the treatment effect of ASF-1075 cream 5% with regard to: oAtopic dermatitis signs and symptoms other than pruritus oClinical score - EASI oGlobal improvement assessed by the investigator oGlobal improvement assessed by the patient oPatient assessed quality of life •To assess the safety and local tolerance profile in the ASF-1075 cream 5% group ;Primary end point(s): The primary endpoint is pruritus due to atopic dermatitis (AD) evaluated in the clinic using a 100 mm visual analogue scale (VAS) after 3 weeks treatment compared to baseline. The secondary endpoints are: •Pruritus due to AD after 1 and 2 weeks treatment compared to baseline assessed in the clinic using the 100mm VAS. •Effect on patient daily reported pruritus in a diary, using average for the last three days within each week, at baseline and at 1, 2 and 3 weeks using the 4-point verbal rating scale according to EASI. •Onset of effect using the above mentioned diary data •Clinical score using Eczema Area and Severity Index (EASI). •Investigator’s Global Assessment (IGA) of AD on a 6-point verbal rating scale. •Patient’s Global Assessment of AD on a 4-point verbal rating scale. •Number of applications in the two groups during week 1. •Quality of Life assessed by the patient using the DLQI. •Adverse events. | — |
Countries
Denmark
Outcome results
None listed