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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914186
• Other study ID #: TS022-US201
• Status: Completed
• Phase: Phase 2
• First received: May 28, 2009
• Last updated: November 30, 2011
• Start date: June 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2011
• Source: Taisho Pharmaceutical R&D Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

(none provided)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Pruritus

Intervention

Drug:
• TS022
Lotion
• Vehicle
Lotion

Locations

Country	Name	City	State
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	J & S Studies	College Station	Texas
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Center for Clinical Studies	Houston	Texas
United States	Ameriderm Research	Jacksonville	Florida
United States	Ameriderm Research	Kissimmee	Florida
United States	UCSD	La Jolla	California
United States	FXM Research	Miramar	Florida
United States	Ameriderm Research	Ormond Beach	Florida
United States	Oregon Health and Science University	Portland	Oregon
United States	Therapeutics Clinical Research	San Diego	California
United States	Gwinnett Clinical Research	Snellville	Georgia
United States	Haber Dermatology and Cosmetic Surgery, Inc	South Euclid	Ohio
United States	Center for Clinical Studies	Webster	Texas
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical R&D Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Baseline through Study Day 36 (Visit 7)	No
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	Baseline through Study Day 36 (Visit 7)	Yes
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)	baseline through Study Day 36 (Visit 7)	No
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)	Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7)	No
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.	baseline through Study Day 36 (Visit 7)	No
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.	Study Day -7 through Study Day 22	No
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.	Baseline through Study Day 36 (Visit 7)	No