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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Vehicle; Drug: TS022

• Registration Number: NCT00914186
• Lead Sponsor: Taisho Pharmaceutical R&D Inc.

Brief 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.

Detailed Description

(none provided)

Study Timeline

• Study First Submitted: 2009-05-28
• Study Start: 2009-06
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-04
• Primary Completion: 2010-05
• Study Completion: 2010-10
• Results First Submitted: 2011-02-28
• Status Verified: 2011-11
• Results First Submitted QC: 2011-11-10
• Results First Posted: 2011-11-17
• Last Update Submitted: 2011-11-30
• Last Update Posted: 2011-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	-
TS-022 0.005% lotion	TS022	-
TS-022 0.010% lotion	TS022	-
TS-022 0.020% lotion	TS022	-

Primary Outcome Measures

Name	Time	Method
Change in Pruritis Visual Analog Scale (VAS)	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
Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events	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
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.	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.
Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale	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.
Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas	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)
Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score	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)
Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas	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.

Trial Locations

Locations (12)

UCSD; 🇺🇸 La Jolla, California, United States

J & S Studies; 🇺🇸 College Station, Texas, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

FXM Research; 🇺🇸 Miramar, Florida, United States

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Ameriderm Research; 🇺🇸 Ormond Beach, Florida, United States

Gwinnett Clinical Research; 🇺🇸 Snellville, Georgia, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Haber Dermatology and Cosmetic Surgery, Inc; 🇺🇸 South Euclid, Ohio, United States

Center for Clinical Studies; 🇺🇸 Webster, Texas, United States

Comprehensive Clinical Research; 🇺🇸 Berlin, New Jersey, United States