Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT04753034 |
Recruitment Status :
Completed
First Posted : February 12, 2021
Results First Posted : July 19, 2022
Last Update Posted : July 26, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atopic Dermatitis | Drug: TER-101 Drug: Vehicle | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | January 18, 2021 |
Actual Primary Completion Date : | May 3, 2021 |
Actual Study Completion Date : | May 3, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: TER-101
BID (twice daily) application
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Drug: TER-101
Active Comparator |
Placebo Comparator: Vehicle
Vehicle ointment, BID (twice daily) application
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Drug: Vehicle
Placebo Comparator |
- Percent Change in EASI From Baseline at Day 29 [ Time Frame: 29 days ]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.
- Changes in EASI Over Time [ Time Frame: 15 days ]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.
- Change in IGA From Baseline Over Time [ Time Frame: 29 Days ]
IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear
- = Almost Clear
- = Mild
- = Moderate
- = Severe
- Changes in Itch Over Time [ Time Frame: 29 days ]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".
- Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD [ Time Frame: 29 days ]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)

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Ages Eligible for Study: | 12 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04753034
United States, Arizona | |
Teres Bio site 05 | |
Scottsdale, Arizona, United States, 85255 | |
United States, California | |
Teres Bio Site 04 | |
Encinitas, California, United States, 92024 | |
United States, Florida | |
Teres Bio Site 12 | |
North Miami Beach, Florida, United States, 33162 | |
Teres Bio Site 10 | |
Tampa, Florida, United States, 33613 | |
United States, Indiana | |
Teres Bio Site 02 | |
Clarksville, Indiana, United States, 47129 | |
United States, Kentucky | |
Teres Bio Site 01 | |
Louisville, Kentucky, United States, 40241 | |
United States, Missouri | |
Teres Bio site 09 | |
Saint Joseph, Missouri, United States, 64506 | |
United States, North Carolina | |
Teres Bio Site 08 | |
High Point, North Carolina, United States, 27262 | |
Teres Bio Site 11 | |
Wilmington, North Carolina, United States, 28405 | |
United States, Texas | |
Teres Bio Site 03 | |
College Station, Texas, United States, 77845 | |
Teres Bio Site 06 | |
Pflugerville, Texas, United States, 78660 | |
Teres Bio Site 07 | |
San Antonio, Texas, United States, 78229 |
Documents provided by Teres Bio, Inc.:
Responsible Party: | Teres Bio, Inc. |
ClinicalTrials.gov Identifier: | NCT04753034 |
Other Study ID Numbers: |
TER101-AD-201 |
First Posted: | February 12, 2021 Key Record Dates |
Results First Posted: | July 19, 2022 |
Last Update Posted: | July 26, 2022 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |