Pruritus, Atopic Dermatitis Clinical Trial
Official title:
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.
| Verified date | October 2009 |
| Source | Serentis Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 62 |
| Est. completion date | August 2009 |
| Est. primary completion date | July 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Serentis Ltd. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measure of intensity and duration of itch episodes | Duration of episode | No | |
| Secondary | Safety and local dermal tolerability | 4 weeks | Yes |