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Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)
This study is currently recruiting participants.
Verified by Taisho Pharmaceutical R&D Inc., June 2009
First Received: May 28, 2009   Last Updated: June 2, 2009   History of Changes
Sponsored by: Taisho Pharmaceutical R&D Inc.
Information provided by: Taisho Pharmaceutical R&D Inc.
ClinicalTrials.gov Identifier: NCT00914186
  Purpose

The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe pruritus (itching), following a 28-day regimen of twice-daily topical application.


Condition Intervention Phase
Atopic Dermatitis
Moderate to Very Severe Pruritus
Drug: TS022
Drug: Vehicle
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy, Safety and Tolerability of TS-022 in Adult Patients With a Diagnosis of Atopic Dermatitis (AD) With Moderate to Very Severe Pruritus

Resource links provided by NLM:


Further study details as provided by Taisho Pharmaceutical R&D Inc.:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) [ Time Frame: Twice Daily ] [ Designated as safety issue: No ]
  • Evaluate safety and tolerability of TS-022 topical lotion for 28 days; assessing adverse events, vital signs, laboratory findings, physical exams, electrocardiograms [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Investigator's Global Assessment (IGA) [ Time Frame: Week 1, Week 2, Week 3, Week 4 and Week 6 ] [ Designated as safety issue: No ]
  • Five Point Pruritus Scale [ Time Frame: Twice Daily ] [ Designated as safety issue: No ]
  • Eczema Area and Severity Index (EASI) [ Time Frame: Week 1, Week 2, Week 3, Week 4 and Week 6 ] [ Designated as safety issue: No ]
  • Skindex-29 Quality of Life Determination [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: June 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TS022: Experimental Drug: TS022
Lotion
Vehicle: Placebo Comparator Drug: Vehicle
Lotion

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults, males or females, 18 - 55 years of age at the time of obtaining the written Informed Consent
  2. Generally healthy subjects, who have no past or present history of any significant and/or newly-diagnosed disease or condition
  3. A score of 2 (Mild Disease), 3 (Moderate Disease) or 4 (Severe Disease) on the Investigator's Global Assessment of Atopic Dermatitis (IGA) Scale
  4. A score of 2 (Moderate Pruritus), 3 (Severe Pruritus) or 4 (Very Severe Pruritus) on the Five-Point Pruritus Scale
  5. Patient satisfies the diagnostic criteria for AD as determined by the criteria of Hanifin and Rajka
  6. Patient understands the study procedures and agrees to participate in the study by giving written Informed Consent
  7. Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

  1. Concurrent skin pathology or recent history (within the past 5 years) of a chronic skin disease other than AD
  2. Use of phototherapy, including exposure to tanning beds, within 28 days of Study Drug application
  3. Taking systemic immunosuppressive drugs, biologicals, or corticosteroids therapy within (14 days), or topical immunosuppressive drugs or corticosteroid therapy (within 7 days) of Study Drug application
  4. Females who are planning a pregnancy, who are pregnant, or who are breastfeeding
  5. Inability or unwillingness to discontinue current AD treatment(s)
  6. Inability or unwillingness to comply with study visit schedule and/or other study activities as required by the study protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914186

Contacts
Contact: Monica Williams 484-991-8021 mwilliams@clinsys.com

Locations
United States, California
Recruiting
Fremont, California, United States, 94538
Recruiting
La Jolla, California, United States, 92037
United States, Florida
Recruiting
Kissimmee, Florida, United States, 34741
Recruiting
Ormond Beach, Florida, United States, 32174
United States, Georgia
Recruiting
Snellville, Georgia, United States, 30078
United States, Kentucky
Recruiting
Louisville, Kentucky, United States, 40202
United States, Minnesota
Recruiting
Fridley, Minnesota, United States, 55432
United States, New Jersey
Recruiting
Berlin, New Jersey, United States, 08009
United States, North Carolina
Recruiting
Raleigh, North Carolina, United States, 27612
Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Recruiting
South Euclid, Ohio, United States, 44118
United States, Oregon
Recruiting
Portland, Oregon, United States, 97239
United States, Texas
Recruiting
College Station, Texas, United States, 77845
Recruiting
Houston, Texas, United States, 77030
Recruiting
Webster, Texas, United States, 77598
Sponsors and Collaborators
Taisho Pharmaceutical R&D Inc.
  More Information

No publications provided

Responsible Party: Taisho Pharmaceutical R&D Inc.
Study ID Numbers: TS022-US201
Study First Received: May 28, 2009
Last Updated: June 2, 2009
ClinicalTrials.gov Identifier: NCT00914186     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Taisho Pharmaceutical R&D Inc.:
Atopic Dermatitis
Pruritus

Study placed in the following topic categories:
Pruritus
Signs and Symptoms
Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

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

ClinicalTrials.gov processed this record on September 03, 2009