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

Atopic Dermatitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379910
• Other study ID #: 1030-260-01
• Secondary ID: 2014-003684-38
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 19, 2015
• Last updated: December 10, 2015
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: AnaMar AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• AM1030-CREAM or placebo

Locations

Country	Name	City	State
United Kingdom	Covance CRU	Leeds
United Kingdom	CRLCRU Royal Liverpool University Hospital	Liverpool

Sponsors (2)

Lead Sponsor	Collaborator
AnaMar AB	Covance

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of adverse events as a measure of Safety	Day 1-15	Yes
Primary	Local Tolerability: Change in Erythema (Likert scale 0-4)	Change in Erythema (Likert scale 0-4) as a measure of Local Tolerability	Day 1-15	Yes
Primary	Local Tolerability: Change in Oedema (Likert scale 0-3)	Change in Oedema (Likert scale 0-3) as a measure of Local Tolerability	Day 1-15	Yes
Primary	Local Tolerability: Change in Burning (Likert scale 0-3)	Change in Burning (Likert scale 0-3) as a measure of Local Tolerability	Day 1-15	Yes
Primary	Local Tolerability: Change in Prutitus (VAS)	Change in Prutitus (VAS) as a measure of Local Tolerability	Day 1-15	Yes
Primary	Vital Signs	Change in blood pressure as a measure of Safety	Day 1-15	Yes
Primary	Vital Signs	Change in pulse rate as a measure of Safety	Day 1-15	Yes
Primary	Vital Signs	Change in body temperature as a measure of Safety	Day 1-15	Yes
Primary	ECG	Change in ECG as a measure of Safety	Day 1-15	Yes
Primary	Physical Examination	Any abnormal observations from Physical Examination as a measure of Safety	Day 1-15	Yes
Secondary	Pharmacokinetics: Cmax, AUC, tmax, t1/2, Vss/F, CL/F	Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2, Vss/F, CL/F	Profil Day 1-15	No
Secondary	Pruritus on a Visual Analog Scale	Pruritus (Visual Analog Scale 10 cm) as a measure of Efficacy	Day 1-15	No
Secondary	Erythema on a Likert scale	Erythema (Likert Scale 0-4) as a measure of Efficacy	Day 1-15	No
Secondary	Modified Eczema Area and Severity Index (mEASI)	mEASI (Composite score 0-64.8) as a measure of Efficay	Day 1-15	No