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

November 30, 2011 updated by: Taisho Pharmaceutical R&D Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

(none provided)

Study Type

Interventional

Enrollment (Actual)

122

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

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

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Lotion
Experimental: TS-022 0.005% lotion
Lotion
Experimental: TS-022 0.010% lotion
Lotion
Experimental: TS-022 0.020% lotion
Lotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pruritis Visual Analog Scale (VAS)
Time Frame: Baseline through Study Day 36 (Visit 7)
Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale
Baseline through Study Day 36 (Visit 7)
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)
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
Baseline through Study Day 36 (Visit 7)
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)
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)
baseline through 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)
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)
Baseline, which is Day -7 (Visit 2), through 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)
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.
baseline through Study Day 36 (Visit 7)
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
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.
Study Day -7 through Study Day 22
Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale
Time Frame: Baseline through Study Day 36 (Visit 7)
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.
Baseline through Study Day 36 (Visit 7)

Collaborators and Investigators

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

Investigators

  • Study Director: Nermina Nakas, MD, Clinsys

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

June 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

December 1, 2011

Last Update Submitted That Met QC Criteria

November 30, 2011

Last Verified

November 1, 2011

More Information

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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