Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taisho Pharmaceutical R&D Inc.
ClinicalTrials.gov Identifier:
NCT00914186
First received: May 28, 2009
Last updated: November 30, 2011
Last verified: November 2011
  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
Drug: TS022
Drug: Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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:
  • Change in Pruritis Visual Analog Scale (VAS) [ Time Frame: Baseline through Study Day 36 (Visit 7) ] [ Designated as safety issue: No ]
    Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale

  • Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events [ Time Frame: Baseline through Study Day 36 (Visit 7) ] [ Designated as safety issue: Yes ]
    Safety assessment of all subjects who received investigational product. Outcome measure is number of subjects with an adverse event. Measures of adverse events in participants included vital signs, laboratory findings, physical exams, electrocardiograms

  • Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas [ Time Frame: baseline through Study Day 36 (Visit 7) ] [ Designated as safety issue: No ]
    investigator assessment of disease status rated on 0-5 scale (0 = clear to 5 = very severe) based on a change in score from baseline to Study Day 36 (Visit 7)

  • Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score [ Time Frame: Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7) ] [ Designated as safety issue: No ]
    self-assessment using a five point scale of pruritus state based on a change in scale from none (0) to very severe (4), interfering with daily or sleep activities. Subjects will complete the Five-Point Pruritus Scale once at Screening (Visit 1), then twice daily beginning at baseline, which occurs on the morning of Study Day -7 (Visit 2), through Study Day 36 (Visit 7)

  • Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas [ Time Frame: baseline through Study Day 36 (Visit 7) ] [ Designated as safety issue: No ]
    The head and neck [10%], trunk [30%], upper extremities [20%] and lower extremities [40%] were assessed separately for erythema (E), infiltration/papulation (I), excoriation (Ex) and lichenification (L) represented by a numeric coded value of (0, No eruption) to (6, 90% - 100% eruption). One score given to each part of the body on a scale from 1-6 based on the four attributes (E, I, Ex, L) and then a proportional average is taken to get a total score of 1-6.

  • Skindex-29 Questionnaire to Measure the Subject's Overall Quality of Life Based on Activities of Daily Living That Affect Change in Emotion (10 to 50 Points), Symptoms (7 to 35 Points) and Functioning (12 to 60 Points) to Skin Over One Week Period. [ Time Frame: Study Day -7 through Study Day 22 ] [ Designated as safety issue: No ]
    Assessment of subject's activities of daily living using the SKINDEX-29 questionnaire to measure the subject's overall quality of life based on a change in scale from baseline. The SKINDEX scoring scale has a range of 29-145. The smaller the number the better the patient feels. The results are the difference of the SKINDEX scoring scale at treatment discharge (day 22) minus baseline (day-7). Hence the results should be negative, as the patient's emotion, symptoms and functioning of the skin should feel better at treatment discharge as opposed to baseline.

  • Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale [ Time Frame: Baseline through Study Day 36 (Visit 7) ] [ Designated as safety issue: No ]
    Pruritis Visual Analog Scale (VAS) based on patient reported outcome of pruritis measurement on a VAS indicating the amount of pruritus (itchiness) experienced from the time of last dose application through the time just before current dose application. Change in pruritus is assessed twice daily beginning at baseline, Study Day -7 (Visit 2), through Study Day 36 (Visit 7). Subjects determine measurable pruritis using a visual horizontal analog scale ranging from "No Itch", even the slightest itch or "Slight Itch", to "Worst Itch Imaginable" to denote the increase in severity of itching.


Enrollment: 122
Study Start Date: June 2009
Study Completion Date: October 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle Drug: Vehicle
Lotion
Experimental: TS-022 0.005% lotion Drug: TS022
Lotion
Experimental: TS-022 0.010% lotion Drug: TS022
Lotion
Experimental: TS-022 0.020% lotion Drug: TS022
Lotion

Detailed Description:

(none provided)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults, males or females, 18 - 65 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

Locations
United States, California
UCSD
La Jolla, California, United States, 92037
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Florida
Ameriderm Research
Jacksonville, Florida, United States, 32216
Ameriderm Research
Kissimmee, Florida, United States, 34741
FXM Research
Miramar, Florida, United States, 33027
Ameriderm Research
Ormond Beach, Florida, United States, 32174
United States, Georgia
Gwinnett Clinical Research
Snellville, Georgia, United States, 30078
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Haber Dermatology and Cosmetic Surgery, Inc
South Euclid, Ohio, United States, 44118
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
J & S Studies
College Station, Texas, United States, 77845
Center for Clinical Studies
Houston, Texas, United States, 77030
Center for Clinical Studies
Webster, Texas, United States, 77598
Sponsors and Collaborators
Taisho Pharmaceutical R&D Inc.
Investigators
Study Director: Nermina Nakas, MD Clinsys
  More Information

No publications provided

Responsible Party: Taisho Pharmaceutical R&D Inc.
ClinicalTrials.gov Identifier: NCT00914186     History of Changes
Other Study ID Numbers: TS022-US201
Study First Received: May 28, 2009
Results First Received: February 28, 2011
Last Updated: November 30, 2011
Health Authority: United States: Food and Drug Administration

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

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 April 16, 2014