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

Study Overview
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Brief Summary
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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.

Detailed Description
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(none provided)

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: TS022
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, males or females, 18 - 65 years of age at the time of obtaining the written Informed Consent Generally healthy subjects, who have no past or present history of any significant and/or newly-diagnosed disease or condition A score of 2 (Mild Disease), 3 (Moderate Disease) or 4 (Severe Disease) on the Investigator's Global Assessment of Atopic Dermatitis (IGA) Scale A score of 2 (Moderate Pruritus), 3 (Severe Pruritus) or 4 (Very Severe Pruritus) on the Five-Point Pruritus Scale Patient satisfies the diagnostic criteria for AD as determined by the criteria of Hanifin and Rajka Patient understands the study procedures and agrees to participate in the study by giving written Informed Consent Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure Exclusion Criteria: Concurrent skin pathology or recent history (within the past 5 years) of a chronic skin disease other than AD Use of phototherapy, including exposure to tanning beds, within 28 days of Study Drug application 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 Females who are planning a pregnancy, who are pregnant, or who are breastfeeding Inability or unwillingness to discontinue current AD treatment(s) Inability or unwillingness to comply with study visit schedule and/or other study activities as required by the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* Lotion<br>|
| Experimental: TS-022 0.005% lotion<br> | Drug: TS022<br>* Lotion<br>|
| Experimental: TS-022 0.010% lotion<br> | Drug: TS022<br>* Lotion<br>|
| Experimental: TS-022 0.020% lotion<br> | Drug: TS022<br>* Lotion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Pruritus