A Phase II, Double-Blind, Vehicle Controlled Study to Determine the Efficacy, Safety and Toleration of SRD441 Ointment in Patients With Atopic Dermatitis

Serentis Ltd.0 sites93 target enrollmentApril 2009

ConditionsAtopic Dermatitis

InterventionsOintment Vehicle ointment

DrugsOintment

Overview

Phase: Phase 2
Intervention: Ointment
Conditions: Atopic Dermatitis
Sponsor: Serentis Ltd.
Enrollment: 93
Primary Endpoint: Measure efficacy in treating acute exacerbations
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Atopic Dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children and 2 to 10% of adults. AD is characterised by an itchy skin eruption and may cover large parts of the body. The exact cause is unknown but is thought to be an interplay between genetic and and environmental factors. The objective of this study is to determine whether SRD441 ointment is a safe and effective therapy for mild to moderate Atopic Dermatitis.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

October 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Serentis Ltd.

Eligibility Criteria

Inclusion Criteria

•Male and female subjects aged 18 or over
•Subjects with a history of AD
•Written and dated informed consent
•Satisfactory medical assessment with no clinical relevant abnormalities.

Exclusion Criteria

•Subjects with current or recurrent disease (except AD) that could affect the site of application, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
•Subjects who have medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
•Subjects with any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible drug application sites which could impact the application of the test agent or confound the local assessments during this study.
•Subjects with clinically significant renal and liver parameters, as defined as greater than 1.5 x creatinine and 3 x AST ULN (upper limit of normal) respectively.