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

AnaMar

Status and phase: Completed; Phase 2; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: AM1030-CREAM or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02379910

1030-260-01

2014-003684-38 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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36 participants in 5 patient groups

SAD 1

Experimental group

Description:

AM1030-CREAM

Treatment:

Drug: AM1030-CREAM or placebo

SAD 2

Experimental group

Description:

AM1030-CREAM

Treatment:

Drug: AM1030-CREAM or placebo

SAD 3

Experimental group

Description:

AM1030-CREAM

Treatment:

Drug: AM1030-CREAM or placebo

MAD 1

Experimental group

Description:

AM1030-CREAM

Treatment:

Drug: AM1030-CREAM or placebo

MAD 2

Experimental group

Description:

AM1030-CREAM

Treatment:

Drug: AM1030-CREAM or placebo