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

NCT00914186 | Completed Phase 2 Results

• 1 other identifier: TS022-US201
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 15

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Pruritus

Outcome Measures

Primary Outcomes (7)

• 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)

Study Arms (4)

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

TS-022 0.005% lotion

EXPERIMENTAL

Drug: TS022

TS-022 0.010% lotion

EXPERIMENTAL

Drug: TS022

TS-022 0.020% lotion

EXPERIMENTAL

Drug: TS022

Interventions

TS022 DRUG

Lotion

TS-022 0.005% lotion; TS-022 0.010% lotion; TS-022 0.020% lotion

Vehicle DRUG

Lotion

Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taisho Pharmaceutical R&D Inc.: lead

Study Sites (15)

UCSD

La Jolla, California, 92037, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Ameriderm Research

Jacksonville, Florida, 32216, United States

Location

Ameriderm Research

Kissimmee, Florida, 34741, United States

Location

FXM Research

Miramar, Florida, 33027, United States

Location

Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Gwinnett Clinical Research

Snellville, Georgia, 30078, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Haber Dermatology and Cosmetic Surgery, Inc

South Euclid, Ohio, 44118, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

J & S Studies

College Station, Texas, 77845, United States

Location

Center for Clinical Studies

Houston, Texas, 77030, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Slower than expected enrollment and a higher than expected screen failure rate.

Results Point of Contact

• Title: Fred Henry MS, MPH,
• Organization: Taisho Pharmaceutical R&D Inc.

F-Henry@taihso-rd.com

973-898-6200

Study Officials

• Nermina Nakas, MD

  Clinsys

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: June 4, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 1, 2011
• Results First Posted: November 17, 2011

Record last verified: 2011-11

Locations

US (15)