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

NCT ID: NCT02379910

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-06-30

Brief Summary

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

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SAD 1

AM1030-CREAM

Group Type EXPERIMENTAL

AM1030-CREAM or placebo

Intervention Type DRUG

SAD 2

AM1030-CREAM

Group Type EXPERIMENTAL

AM1030-CREAM or placebo

Intervention Type DRUG

SAD 3

AM1030-CREAM

Group Type EXPERIMENTAL

AM1030-CREAM or placebo

Intervention Type DRUG

MAD 1

AM1030-CREAM

Group Type EXPERIMENTAL

AM1030-CREAM or placebo

Intervention Type DRUG

MAD 2

AM1030-CREAM

Group Type EXPERIMENTAL

AM1030-CREAM or placebo

Intervention Type DRUG

Interventions

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AM1030-CREAM or placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Covance

INDUSTRY

Sponsor Role collaborator

AnaMar AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jim Bush

Role: PRINCIPAL_INVESTIGATOR

Covance CRU

Locations

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Covance CRU

Leeds, , United Kingdom

Site Status

CRLCRU Royal Liverpool University Hospital

Liverpool, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2014-003684-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1030-260-01

Identifier Type: -

Identifier Source: org_study_id