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CompletedNCT00914186Updated Dec 1, 2011Results posted

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

A Phase 2 interventional study of TS022 and Vehicle in Atopic Dermatitis, sponsored by Taisho Pharmaceutical R&D Inc.. Completed at 15 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-12-01.

Sponsored by Taisho Pharmaceutical R&D Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

(none provided)

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Atopic Dermatitis
  • Pruritus
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 122 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Taisho Pharmaceutical R&D Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
122 participants (actual)

Study arms

  • Placebo comparator
    Vehicle

    Drug: Vehicle

  • Experimental
    TS-022 0.005% lotion

    Drug: TS022

  • Experimental
    TS-022 0.010% lotion

    Drug: TS022

  • Experimental
    TS-022 0.020% lotion

    Drug: TS022

Interventions

  • DrugTS022

    Lotion

  • DrugVehicle

    Lotion

06

What researchers measure

Primary outcomes

  1. Change in Pruritis Visual Analog Scale (VAS)

    Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale

    Time frame: Baseline through Study Day 36 (Visit 7)

  2. Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events

    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

    Time frame: Baseline through Study Day 36 (Visit 7)

  3. Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas

    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)

    Time frame: baseline through Study Day 36 (Visit 7)

  4. Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score

    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)

    Time frame: Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7)

  5. Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas

    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.

    Time frame: baseline through Study Day 36 (Visit 7)

  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.

    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.

    Time frame: Study Day -7 through Study Day 22

  7. Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale

    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.

    Time frame: Baseline through Study Day 36 (Visit 7)

07

Results

Posted Nov 17, 2011
Limitations and caveats
Slower than expected enrollment and a higher than expected screen failure rate.

Participant flow

Recruitment period for the study started 03Jun09. It was the responsibility of the PI for advertisement and recruitment of the study.

Participant flow — Overall Study
MilestoneVehicleTS-022 0.005%TS-022 0.010%TS-022 0.020%
Started31303130
Completed28282920
Not completed32210

Outcome measures

PrimaryChange in Pruritis Visual Analog Scale (VAS)

Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale

Time frame:
Baseline through Study Day 36 (Visit 7)
Reported as:
Mean · mm
Change in Pruritis Visual Analog Scale (VAS)
mmVehicleTS-022 0.005%TS-022 0.010%TS-022 0.020%
Change in Pruritis Visual Analog Scale (VAS)-12.4 ± 14.09-15.5 ± 18.38-13.9 ± 21.11-6.2 ± 18.82
PrimarySafety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events

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

Time frame:
Baseline through Study Day 36 (Visit 7)
Reported as:
Number · participants
Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events
participantsVehicleTS-022 0.005%TS-022 0.010%TS-022 0.020%
Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events9111011
PrimaryInvestigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas

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)

Time frame:
baseline through Study Day 36 (Visit 7)
Reported as:
Mean · units on a scale
Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas
units on a scaleVehicleTS-022 0.005%TS-022 0.010%TS-022 0.020%
Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas-0.6 (-0.9 to -0.3)-0.5 (-0.8 to -0.2)-0.6 (-0.8 to -0.2)-0.6 (-0.8 to -0.2)
PrimaryFive Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score

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)

Time frame:
Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7)
Reported as:
Mean · units on a scale
Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score
units on a scaleVehicleTS-022 0.005%TS-022 0.010%TS-022 0.020%
Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score-0.4 (-0.7 to -0.2)-0.5 (-0.6 to -0.1)-0.6 (-0.9 to -0.3)-0.2 (-0.5 to -0.1)
PrimaryEczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas

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.

Time frame:
baseline through Study Day 36 (Visit 7)
Reported as:
Mean · units on a scale
Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas
units on a scaleVehicleTS-022 0.005%TS-022 0.010%TS-022 0.020%
Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas-3.1 ± 4.75-2.1 ± 5.09-2.7 ± 3.87-2.3 ± 4.50
PrimarySkindex-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.

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.

Time frame:
Study Day -7 through Study Day 22
Reported as:
Mean · units on a scale
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.
units on a scaleVehicleTS-022 0.005%TS-022 0.010%TS-022 0.020%
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.-11.7 ± 11.61-12.1 ± 14.79-12.3 ± 17.56-4.1 ± 12.43
PrimaryNumber of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale

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.

Time frame:
Baseline through Study Day 36 (Visit 7)
Reported as:
Number · participants
Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale
participantsVehicleTS-022
Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale29 (12.4 to 14.09)78 (15.5 to 18.82)

Adverse events

Collected over Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vehicle—0/31 (0%)9/31 (29%)
TS-022 0.005%—0/30 (0%)11/30 (36.7%)
TS-022 0.010%—0/31 (0%)10/31 (32.3%)
TS-022 0.020%—0/30 (0%)11/30 (36.7%)
Most frequent other events
Most frequent other events
EventVehicleTS-022 0.005%TS-022 0.010%TS-022 0.020%
Dermatitis AtopicSkin and subcutaneous tissue disorders1/312/302/315/30
HeadacheNervous system disorders3/312/302/311/30
Uppper respiratory infectionInfections and infestations0/310/303/310/30
Stomach DiscomfortGastrointestinal disorders0/312/300/311/30
PyrexiaGeneral disorders0/312/300/310/30
ECG AbnormalInvestigations0/310/301/312/30
PruritusSkin and subcutaneous tissue disorders0/311/300/312/30
LymphadenopathyBlood and lymphatic system disorders2/312/300/310/30
ArthralgiaMusculoskeletal and connective tissue disorders1/310/302/310/30
NauseaGastrointestinal disorders2/310/302/310/30

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)VehicleTS-022 0.005%TS-022 0.010%TS-022 0.020%Total
<=18 years00000
Between 18 and 65 years31303130122
>=65 years00000
Age Continuous
Age Continuous(years)VehicleTS-022 0.005%TS-022 0.010%TS-022 0.020%Total
Mean37.5 ± 13.5338.0 ± 11.6335.1 ± 13.7839.0 ± 13.8936.4 ± 13.23
Sex: Female, Male
Sex: Female, Male(Participants)VehicleTS-022 0.005%TS-022 0.010%TS-022 0.020%Total
Female1921172077
Male129141045
Region of Enrollment
Region of Enrollment(participants)VehicleTS-022 0.005%TS-022 0.010%TS-022 0.020%Total
United States31303130122
08

Study locations

15 sites
  • UCSD
    La Jolla, California 92037, United States
  • Therapeutics Clinical Research
    San Diego, California 92123, United States
  • Ameriderm Research
    Jacksonville, Florida 32216, United States
  • Ameriderm Research
    Kissimmee, Florida 34741, United States
  • FXM Research
    Miramar, Florida 33027, United States
  • Ameriderm Research
    Ormond Beach, Florida 32174, United States
  • Gwinnett Clinical Research
    Snellville, Georgia 30078, United States
  • Minnesota Clinical Study Center
    Fridley, Minnesota 55432, United States
  • Comprehensive Clinical Research
    Berlin, New Jersey 08009, United States
  • Wake Forest University
    Winston-Salem, North Carolina 27157, United States
  • Haber Dermatology and Cosmetic Surgery, Inc
    South Euclid, Ohio 44118, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • J & S Studies
    College Station, Texas 77845, United States
  • Center for Clinical Studies
    Houston, Texas 77030, United States
  • Center for Clinical Studies
    Webster, Texas 77598, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00914186
Lead sponsor
Taisho Pharmaceutical R&D Inc.
Responsible party
Sponsor
First posted
Jun 4, 2009
Start date
Jun 2009
Primary completion
May 2010
Completion
Oct 2010
Results posted
Nov 17, 2011
Last update
Dec 1, 2011

Study contacts

Nermina Nakas, MD
study director · Clinsys

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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