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Completed

NCT Number: NCT02379910

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

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Covance CRU, Leeds, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AM1030-CREAM or placebo

Drug

Primary outcomes

  1. Adverse Events

    Time frame: Day 1-15

    Number of adverse events as a measure of Safety

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

    Time frame: Day 1-15

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

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

    Time frame: Day 1-15

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

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

    Time frame: Day 1-15

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

  5. Local Tolerability: Change in Prutitus (VAS)

    Time frame: Day 1-15

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

  6. Vital Signs

    Time frame: Day 1-15

    Change in blood pressure as a measure of Safety

  7. Vital Signs

    Time frame: Day 1-15

    Change in pulse rate as a measure of Safety

  8. Vital Signs

    Time frame: Day 1-15

    Change in body temperature as a measure of Safety

  9. ECG

    Time frame: Day 1-15

    Change in ECG as a measure of Safety

  10. Physical Examination

    Time frame: Day 1-15

    Any abnormal observations from Physical Examination as a measure of Safety

Secondary outcomes

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

    Time frame: Profil Day 1-15

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

  2. Pruritus on a Visual Analog Scale

    Time frame: Day 1-15

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

  3. Erythema on a Likert scale

    Time frame: Day 1-15

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

  4. Modified Eczema Area and Severity Index (mEASI)

    Time frame: Day 1-15

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

Sponsors and collaborators

Lead sponsor

AnaMar AB

Industry

Collaborators

  • Covance

Registry information

Official study title

AM1030: A Phase I/II, Double-Blind, Placebo-Controlled, Single and Multiple Ascending (Topical) Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Patients (Male and Female) With Atopic Dermatitis

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2015
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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