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

This study has been completed.
Sponsor:
Information provided by:
Serentis Ltd.
ClinicalTrials.gov Identifier:
NCT00838708
First received: February 5, 2009
Last updated: October 29, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Pruritus, Atopic Dermatitis
Drug: SRD174 Cream
Other: vehicle cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Serentis Ltd.:

Primary Outcome Measures:
  • Measure of intensity and duration of itch episodes [ Time Frame: Duration of episode ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and local dermal tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: January 2009
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle cream Other: vehicle cream
topical vehicle cream
Experimental: SRD174 Cream Drug: SRD174 Cream
topical SRD174 Cream

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838708

Locations
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.
  More Information

No publications provided

Responsible Party: Robert Tansley, Chief Medical Officer, Serentis
ClinicalTrials.gov Identifier: NCT00838708     History of Changes
Other Study ID Numbers: P174954201CD
Study First Received: February 5, 2009
Last Updated: October 29, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014