A Study to Assess the Safety, Tolerability, PK and PD of AM1030-CREAM in Patients With Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: AM1030-CREAM or placebo
- Registration Number
- NCT02379910
- Lead Sponsor
- AnaMar AB
- Brief Summary
This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of AM1030-CREAM in patients with Atopic Dermatitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MAD 2 AM1030-CREAM or placebo AM1030-CREAM MAD 1 AM1030-CREAM or placebo AM1030-CREAM SAD 1 AM1030-CREAM or placebo AM1030-CREAM SAD 2 AM1030-CREAM or placebo AM1030-CREAM SAD 3 AM1030-CREAM or placebo AM1030-CREAM
- Primary Outcome Measures
Name Time Method ECG Day 1-15 Change in ECG as a measure of Safety
Adverse Events Day 1-15 Number of adverse events as a measure of Safety
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
Physical Examination Day 1-15 Any abnormal observations from Physical Examination 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 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 body temperature as a measure of Safety
- Secondary Outcome Measures
Name Time Method Erythema on a Likert scale Day 1-15 Erythema (Likert Scale 0-4) as a measure of Efficacy
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
Modified Eczema Area and Severity Index (mEASI) Day 1-15 mEASI (Composite score 0-64.8) as a measure of Efficay
Pruritus on a Visual Analog Scale Day 1-15 Pruritus (Visual Analog Scale 10 cm) as a measure of Efficacy
Trial Locations
- Locations (2)
Covance CRU
🇬🇧Leeds, United Kingdom
CRLCRU Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom