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

October 29, 2009 updated by: Serentis Ltd.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle cream
Other: vehicle cream
topical vehicle cream
Experimental: SRD174 Cream
Drug: SRD174 Cream
topical SRD174 Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of intensity and duration of itch episodes
Time Frame: Duration of episode
Duration of episode

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and local dermal tolerability
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Serentis Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

February 6, 2009

Study Record Updates

Last Update Posted (Estimate)

October 30, 2009

Last Update Submitted That Met QC Criteria

October 29, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P174954201CD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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