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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Placebo Comparator |
| |
| TS-022 0.005% lotion | Experimental |
| |
| TS-022 0.010% lotion | Experimental |
| |
| TS-022 0.020% lotion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS022 | Drug | Lotion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline through Study Day 36 (Visit 7) |
| 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 | 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 | 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 | 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nermina Nakas, MD | Clinsys | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD | La Jolla | California | 92037 | United States | ||
| Therapeutics Clinical Research |
There was a seven day run-in-period in which subjects self-applied the Vehicle control twice daily.
Recruitment period for the study started 03Jun09. It was the responsibility of the PI for advertisement and recruitment of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | once daily |
| FG001 | TS-022 0.005% | lotion/once daily |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vehicle | Drug | Lotion |
|
| 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. | 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 | 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) |
| 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 |
| TS-022 0.010% |
lotion/once daily |
| FG003 | TS-022 0.020% | lotion/once daily |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | once daily |
| BG001 | TS-022 0.005% | lotion/once daily |
| BG002 | TS-022 0.010% | lotion/once daily |
| BG003 | TS-022 0.020% | lotion/once daily |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Intent To Treat (ITT) analysis | Posted | Mean | Standard Deviation | mm | Baseline through Study Day 36 (Visit 7) |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | 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 | total number of subjects who received study drug. | Posted | Number | participants | Baseline through Study Day 36 (Visit 7) |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | 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) | ITT | Posted | Mean | 95% Confidence Interval | units on a scale | baseline through Study Day 36 (Visit 7) |
|
| |||||||||||||||||||||||||||||||||||
| Primary | 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) | ITT | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7) |
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | ITT analysis | Posted | Mean | Standard Deviation | units on a scale | baseline through Study Day 36 (Visit 7) |
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | ITT | Posted | Mean | Standard Deviation | units on a scale | Study Day -7 through Study Day 22 |
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Number | participants | Baseline through Study Day 36 (Visit 7) |
|
|
Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vehicle | once daily | 0 | 31 | 9 | 31 | ||
| EG001 | TS-022 0.005% | lotion/once daily | 0 | 30 | 11 | 30 | ||
| EG002 | TS-022 0.010% | lotion/once daily | 0 | 31 | 10 | 31 | ||
| EG003 | TS-022 0.020% | lotion/once daily | 0 | 30 | 11 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach Discomfort | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| ECG Abnormal | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Uppper respiratory infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
Slower than expected enrollment and a higher than expected screen failure rate.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fred Henry MS, MPH, | Taisho Pharmaceutical R&D Inc. | 973-898-6200 | F-Henry@taihso-rd.com |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Participants |
|
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|
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| Units | Counts |
|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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lotion/once daily |
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