Clinical trial NCT00914186: Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Pruritus
Lead sponsor: Taisho Pharmaceutical R&D Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pruritis Visual Analog Scale (VAS)
timeFrame: Baseline through Study Day 36 (Visit 7)
measure: Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events
timeFrame: Baseline through Study Day 36 (Visit 7)
measure: Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas
timeFrame: baseline through Study Day 36 (Visit 7)
measure: Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score
timeFrame: Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7)
measure: Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas
timeFrame: baseline through Study Day 36 (Visit 7)
measure: 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.
timeFrame: Study Day -7 through Study Day 22
measure: Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale
timeFrame: Baseline through Study Day 36 (Visit 7)
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Jacksonville
country: United States
facility: Ameriderm Research
state: Florida
city: Kissimmee
country: United States
facility: Ameriderm Research
state: Florida
city: Miramar
country: United States
facility: FXM Research
state: Florida
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: Snellville
country: United States
facility: Gwinnett Clinical Research
state: Georgia
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: South Euclid
country: United States
facility: Haber Dermatology and Cosmetic Surgery, Inc
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: College Station
country: United States
facility: J & S Studies
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
Study officials:
affiliation: Clinsys
name: Nermina Nakas, MD
role: STUDY_DIRECTOR
References: