Atopic Dermatitis Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of TER-101 Topical Ointment to Assess Efficacy and Safety in Subjects With Mild to Moderate Atopic
Verified date | February 2021 |
Source | Teres Bio, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Phase 2 study will assess efficacy, safety, and tolerability of TER-101 ointment and vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic dermatitis.
Status | Completed |
Enrollment | 63 |
Est. completion date | May 3, 2021 |
Est. primary completion date | May 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 65 Years |
Eligibility | Inclusion Criteria: - Adolescent or adult subject aged 12 - 65 years. - Overall IGA score of 2 (mild) or 3 (moderate) at baseline on a 5-point IGA Exclusion Criteria: - AD with known hypersensitivity to excipients of TER-101 Ointment - Subjects who are immunocompromised |
Country | Name | City | State |
---|---|---|---|
United States | Teres Bio Site 02 | Clarksville | Indiana |
United States | Teres Bio Site 03 | College Station | Texas |
United States | Teres Bio Site 04 | Encinitas | California |
United States | Teres Bio Site 08 | High Point | North Carolina |
United States | Teres Bio Site 01 | Louisville | Kentucky |
United States | Teres Bio Site 12 | North Miami Beach | Florida |
United States | Teres Bio Site 06 | Pflugerville | Texas |
United States | Teres Bio site 09 | Saint Joseph | Missouri |
United States | Teres Bio Site 07 | San Antonio | Texas |
United States | Teres Bio site 05 | Scottsdale | Arizona |
United States | Teres Bio Site 10 | Tampa | Florida |
United States | Teres Bio Site 11 | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Teres Bio, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change in EASI From Baseline at Day 29 | EASI = Eczema Area and Severity Index, EASI combines the assessment of the severity of lesions and the the numerical area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for erythema, induration, lichenification, excoriation are multiplied with value of the area affected and with the percentage of the four body areas. | 29 days | |
Secondary | Changes in EASI Over Time | EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for erythema, induration, lichenification, excoriation are multiplied with the numerical value of the area affected and with the percentage of the four body areas. | 15 days | |
Secondary | Change in IGA From Baseline Over Time | IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear
= Almost Clear = Mild = Moderate = Severe |
29 Days | |
Secondary | Changes in Itch Over Time | The WI-NRS asks subjects to report their worst itch (maximal intensity) during the last 24 hours on an 11-point NRS, ranging from 0 = "no itch at all" to 10 = "worst itch you can imagine". | 29 days | |
Secondary | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Sum of erythema, itch, and burning at the time of visit compared to baseline measured on a 0 - 3 scale for each component. A score of 0 indicates no erythema, itch or burning. Higher scores indicate worsening tolerability: 1 (mild), 2 (moderate), 3 (severe) | 29 days |
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