Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus
This study has been completed.
Sponsor:
Serentis Ltd.
Information provided by:
Serentis Ltd.
ClinicalTrials.gov Identifier:
NCT00838708
First received: February 5, 2009
Last updated: October 29, 2009
Last verified: October 2009
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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
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 Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Skin Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013