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

Taisho Pharmaceutical R&D Inc.122 enrolled

Overview

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.

(none provided)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

122

Conditions

Atopic Dermatitis

Interventions

TS022DRUG

Lotion

VehicleDRUG

Lotion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (15)

UCSD

La Jolla, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Ameriderm Research

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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.

Data from ClinicalTrials.gov

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