Safety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Other: Vehicle ointment; Drug: Ointment

• Registration Number: NCT00882245
• Lead Sponsor: Serentis Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Primary Completion: 2009-08
• Status Verified: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2009-10-29
• Last Update Posted: 2009-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle ointment	Vehicle ointment	-
SRD441 Ointment	Ointment	-

Primary Outcome Measures

Name	Time	Method
Measure efficacy in treating acute exacerbations	4 weeks

Secondary Outcome Measures

Name	Time	Method
Safety and local dermal tolerability	4 weeks