Phase 2
N=122
Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT00914186 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcome: Primary: Change in Pruritis Visual Analog Scale (VAS) — -12.4; -15.5; -13.9; -6.2 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TS022 (Drug); Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Taisho Pharmaceutical R&D Inc.
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pruritis Visual Analog Scale (VAS) |
-12.4; -15.5; -13.9; -6.2 | — |
| PRIMARY Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events |
9; 11; 10; 11 | — |
| PRIMARY Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas |
-0.6; -0.5; -0.6; -0.6 | — |
| PRIMARY Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score |
-0.4; -0.5; -0.6; -0.2 | — |
| PRIMARY Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas |
-3.1; -2.1; -2.7; -2.3 | — |
| 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. |
-11.7; -12.1; -12.3; -4.1 | — |
| PRIMARY Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale |
29; 78 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00914186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.