A Phase 2a Study To Investigate The Effects of Repeated Administration of AeroDerm in subjects with Atopic Eczema.

Phase 1

• Conditions: Atopic Eczema: a chronic inflammatory pruritic skin disease that follows a relapsing course and is often associated with elevated serum immunoglobulin E (IgE) levels and a personal or family history of allergies, allergic rhinitis and asthma. It is thought that atopic eczema results from an overactivity of T helper 2 (Th2) lymphocytes and down-regulation of T helper 1 (Th1) activity.

• Registration Number: EUCTR2005-002077-76-GB
• Lead Sponsor: Aerovance Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-05-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

•Adult males and females > 18 years.
•Subjects who currently have allergic eczema with an EASI score in the range of 10-35. Subjects with an EASI score in the range of 36-50 may be included at the discretion of the Investigator.
•Subjects who have been on a stable dose of topical medications for eczema for = 1 month from screening but whose eczema is not adequately responsive to, or controlled by, conventional topical treatments (eg: topical steroids, Tracrolimus, Pimecrolimus).
•Subjects who have not had systemic immunosuppressive therapy (eg systemic steroids) within 1 month of screening.
•Subjects who if female, are not currently pregnant or breast feeding and are using medically acceptable methods of contraception.
•Subjects who have a pre-study medical history, physical examination and vital signs acceptable to the investigator.
•Subjects who have clinical laboratory tests within the reference ranges or clinically acceptable to the investigator.
•Subjects who are negative for HbsAg, hepatitis C antibody and HIV II and I test at screening.
•Subjects who are negative for drugs of abuse tests at screening and admission.
•Subjects with stable, adequately treated medical conditions other than eczema may be enrolled provided the Investigator does not consider their study participation to place them at increased risk of adverse events. Subjects should continue their concomitant treatments for medical conditions (other than eczema).
•Subjects who are able and willing to give written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Subjects who do not conform to the above inclusion criteria.
•Subjects who have the following medical conditions: Diabetes mellitus, Thyroiditis, Rheumatiod arthritis, Multiple sclerosis, Uveitis, Sarcoidosis, Glomerulonephritis, Helminthic infection.
•Subjects who have a history of relevant drug hypersensitivity.
•Subjects who have a history of alcoholism.
•Subjects who have a history of drug abuse.
•Subjects who have a significant infection at the time of screening and/or admission.
•Subjects who are having acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn), may be asked to reschedule their screening and/or admission to when they are not longer having acute symptoms.
•Subjects who have an acute infection such as influenza at the time of screening and/or admission.
•Female subjects who are not using an acceptable method of contraception.
•Subjects who have used any investigational drug and /or participated in any clinical trial within 3 months of their first dosing.
•Subjects who have previously received AeroDerm.
•Subjects using medication, which in the opinion of the Investigator will affect the outcome of the study.
•Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to first dosing (to review on a case by case basis).
•Subjects who cannot communicate reliably with the investigator.
•Subjects who are unlikely to co-operate with the requirements of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified