A Study to Assess the Safety, Tolerability, PK and PD of AM1030-CREAM in Patients With Atopic Dermatitis

AnaMar AB36 enrolled

Overview

This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of AM1030-CREAM in patients with Atopic Dermatitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

AM1030-CREAM or placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Covance CRU

Leeds, United Kingdom

CRLCRU Royal Liverpool University Hospital

Liverpool, United Kingdom

Outcomes

Primary Outcomes

Adverse Events

Number of adverse events as a measure of Safety

Time frame: Day 1-15

Local Tolerability: Change in Erythema (Likert scale 0-4)

Change in Erythema (Likert scale 0-4) as a measure of Local Tolerability

Time frame: Day 1-15

Local Tolerability: Change in Oedema (Likert scale 0-3)

Change in Oedema (Likert scale 0-3) as a measure of Local Tolerability

Time frame: Day 1-15

Local Tolerability: Change in Burning (Likert scale 0-3)

Change in Burning (Likert scale 0-3) as a measure of Local Tolerability

Time frame: Day 1-15

Local Tolerability: Change in Prutitus (VAS)

Change in Prutitus (VAS) as a measure of Local Tolerability

Time frame: Day 1-15

Vital Signs

Change in blood pressure as a measure of Safety

Time frame: Day 1-15

Vital Signs

Change in pulse rate as a measure of Safety

Time frame: Day 1-15

Vital Signs

Change in body temperature as a measure of Safety

Time frame: Day 1-15

ECG

Change in ECG as a measure of Safety

Time frame: Day 1-15

Data from ClinicalTrials.gov

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Secondary Outcomes

Pharmacokinetics: Cmax, AUC, tmax, t1/2, Vss/F, CL/F

Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2, Vss/F, CL/F

Time frame: Profil Day 1-15

Pruritus on a Visual Analog Scale

Pruritus (Visual Analog Scale 10 cm) as a measure of Efficacy

Time frame: Day 1-15

Erythema on a Likert scale

Erythema (Likert Scale 0-4) as a measure of Efficacy

Time frame: Day 1-15

Modified Eczema Area and Severity Index (mEASI)

mEASI (Composite score 0-64.8) as a measure of Efficay

Time frame: Day 1-15