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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00838708
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : October 30, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pruritus, Atopic Dermatitis Drug: SRD174 Cream Other: vehicle cream Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2009
Primary Completion Date : July 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Vehicle cream Other: vehicle cream
topical vehicle cream
Experimental: SRD174 Cream Drug: SRD174 Cream
topical SRD174 Cream

Primary Outcome Measures :
  1. Measure of intensity and duration of itch episodes [ Time Frame: Duration of episode ]

Secondary Outcome Measures :
  1. Safety and local dermal tolerability [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00838708

United States, Alabama
Birmingham, Alabama, United States
United States, Arkansas
Hot Springs, Arkansas, United States
United States, California
Oceanside, California, United States
United States, Florida
Ormond Beach, Florida, United States
United States, Michigan
Detroit, Michigan, United States
Grand Blanc, Michigan, United States
United States, North Carolina
High Point, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Pennsylvania
Hazleton, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
United States, Virginia
Lynchburg, Virginia, United States
United States, Washington
Spokane, Washington, United States
Sponsors and Collaborators
Serentis Ltd.

Responsible Party: Robert Tansley, Chief Medical Officer, Serentis Identifier: NCT00838708     History of Changes
Other Study ID Numbers: P174954201CD
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: October 30, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Skin Manifestations
Signs and Symptoms