Clinical trial NCT00838708: Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pruritus, Atopic Dermatitis
Lead sponsor: Serentis Ltd.
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measure of intensity and duration of itch episodes
timeFrame: Duration of episode
Secondary outcomes:
measure: Safety and local dermal tolerability
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Hot Springs
country: United States
state: Arkansas
city: Oceanside
country: United States
state: California
city: Ormond Beach
country: United States
state: Florida
city: Detroit
country: United States
state: Michigan
city: Grand Blanc
country: United States
state: Michigan
city: High Point
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Hazleton
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Lynchburg
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
References: