Atopic Dermatitis
Conditions
Brief summary
This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of AM1030-CREAM in patients with Atopic Dermatitis.
Interventions
DRUGAM1030-CREAM or placebo
Sponsors
Covance
AnaMar AB
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males and/or females of any ethnic origin between 18 and 65 years of age * Body mass index between 18.0 and 35.0 kg/m2 * Subjects with AD as defined by the Hanifen and Rajka criteria and with mild to severe disease activity (IGA 2-4) * AD lesions amenable to cutaneous treatment located on the trunk and/or limbs
Exclusion criteria
* Subjects with scars, moles, tattoos, sunburn or other blemishes in test areas * Systemic treatment with immunosuppressants, immunomodulators or corticosteroids within 2 weeks prior to dosing * Topical treatment with corticosteroids, antibiotics and/or immunomodulators within 4 days prior to dosing * Treatment with systemic antihistamines within 24 hours of the first dose administration * Treatment with SSRIs within 2 weeks of the first dose administration * Subjects who have received phototherapy within 4 weeks prior to dosing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Day 1-15 | Number of adverse events as a measure of Safety |
| Local Tolerability: Change in Erythema (Likert scale 0-4) | Day 1-15 | Change in Erythema (Likert scale 0-4) as a measure of Local Tolerability |
| Local Tolerability: Change in Oedema (Likert scale 0-3) | Day 1-15 | Change in Oedema (Likert scale 0-3) as a measure of Local Tolerability |
| Local Tolerability: Change in Burning (Likert scale 0-3) | Day 1-15 | Change in Burning (Likert scale 0-3) as a measure of Local Tolerability |
| Local Tolerability: Change in Prutitus (VAS) | Day 1-15 | Change in Prutitus (VAS) as a measure of Local Tolerability |
| Vital Signs | Day 1-15 | Change in blood pressure as a measure of Safety |
| ECG | Day 1-15 | Change in ECG as a measure of Safety |
| Physical Examination | Day 1-15 | Any abnormal observations from Physical Examination as a measure of Safety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Cmax, AUC, tmax, t1/2, Vss/F, CL/F | Profil Day 1-15 | Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2, Vss/F, CL/F |
| Pruritus on a Visual Analog Scale | Day 1-15 | Pruritus (Visual Analog Scale 10 cm) as a measure of Efficacy |
| Erythema on a Likert scale | Day 1-15 | Erythema (Likert Scale 0-4) as a measure of Efficacy |
| Modified Eczema Area and Severity Index (mEASI) | Day 1-15 | mEASI (Composite score 0-64.8) as a measure of Efficay |
Countries
United Kingdom
Outcome results
None listed