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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

May 28, 2009
November 30, 2011
June 2009
May 2010   (final data collection date for primary outcome measure)
  • 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.
  • 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 ]
Complete list of historical versions of study NCT00914186 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)
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.

(none provided)

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: TS022
    Lotion
  • Drug: Vehicle
    Lotion
  • Placebo Comparator: Vehicle
    Intervention: Drug: Vehicle
  • Experimental: TS-022 0.005% lotion
    Intervention: Drug: TS022
  • Experimental: TS-022 0.010% lotion
    Intervention: Drug: TS022
  • Experimental: TS-022 0.020% lotion
    Intervention: Drug: TS022
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
October 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00914186
TS022-US201
No
Taisho Pharmaceutical R&D Inc.
Taisho Pharmaceutical R&D Inc.
Not Provided
Study Director: Nermina Nakas, MD Clinsys
Taisho Pharmaceutical R&D Inc.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP