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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II, Randomised, Double-blind, Vehicle-controlled, Cross-over Study to Determine the Anti-pruritic Efficacy, Safety and Local Dermal Toleration of SRD174 Cream in Subjects With Atopic Dermatitis.

Conditions
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Pruritus, Atopic Dermatitis

Intervention / Treatment
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* Drug: SRD174 Cream
* Other: vehicle cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle cream<br> | Other: vehicle cream<br>* topical vehicle cream<br>|
| Experimental: SRD174 Cream<br> | Drug: SRD174 Cream<br>* topical SRD174 Cream<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of intensity and duration of itch episodes |  | Duration of episode | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and local dermal tolerability |  | 4 weeks |