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Completed

NCT Number: NCT00838708

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

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.

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Key information

Conditions

Pruritus, Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SRD174 Cream

Drug

topical SRD174 Cream

Vehicle cream

Other

topical vehicle cream

Primary outcomes

  1. Measure of intensity and duration of itch episodes

    Time frame: Duration of episode

Secondary outcomes

  1. Safety and local dermal tolerability

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Serentis Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 6, 2009
Registry last updated
Oct 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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