Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus

Phase 2

Completed

• Conditions: Pruritus, Atopic Dermatitis
• Interventions: Other: vehicle cream; Drug: SRD174 Cream

• Registration Number: NCT00838708
• Lead Sponsor: Serentis Ltd.

Brief Summary

Pruritus is an essential feature for the diagnosis of atopic dermatitis and may play an important part in disease progression. Itching has a significant impact on the quality of life of AD sufferers, in particular night-time itching leading to sleep disturbance and subsequent poor daytime performance.

The objective of this study is to determine whether SRD174 Cream is a safe and effective therapy for moderate to severe pruritus associated with atopic dermatitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Primary Completion: 2009-07
• Study Completion: 2009-08
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-29
• Last Update Posted: 2009-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Males and females aged 18 years and over moderate to severe AD pruritus
• Written signed and dated informed consent
• Satisfactory medical assessment with no clinically relevant abnormalities

Exclusion Criteria

• Subject with active and pruritic AD covering a body surface area (BSA) > 20%
• Subject with severe AD defined as an IGA score of 4
• Subject with current or recurrent skin disease (except AD) that could affect the site of application of action, absorption or disposition of the investigational product, or clinical, laboratory assessments.
• Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
• Subject with known or suspected intolerance or hypersensitivity to the Investigational products or any of the stated ingredients.
• Subject who has a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with interpretation of trial results and, in the judgment if the investigator, would make the subject inappropriate for entry into this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vehicle cream	vehicle cream	-
SRD174 Cream	SRD174 Cream	-

Primary Outcome Measures

Name	Time	Method
Measure of intensity and duration of itch episodes	Duration of episode

Secondary Outcome Measures

Name	Time	Method
Safety and local dermal tolerability	4 weeks