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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AnaMar AB
• Collaborator: Covance

Criteria

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