Acne Vulgaris Clinical Trial
— TASEROfficial title:
A Single Center, Phase 4, Open-label Prospective Case Series Study of the Safety and Efficacy of Sarecycline for 12 Weeks in Subjects Ages 9 and Over With Truncal Acne
Verified date | July 2023 |
Source | Arlington Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to determine the efficacy and safety of oral sarecycline 1.5 mg/kg/day in truncal acne. Patients with moderate to severe acne vulgaris will be observed over a period of 12 weeks. Lesion counts, investigator's global assessments, photography, and safety measures will be assessed for the trunk and face.
Status | Completed |
Enrollment | 10 |
Est. completion date | August 31, 2021 |
Est. primary completion date | June 24, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 9 Years to 50 Years |
Eligibility | Inclusion Criteria: - Male or female age 9 or above. - Clinical diagnosis of moderate to severe truncal acne based on IGA Exclusion Criteria: - Known or suspected allergies or sensitivities to any components of the study drug. - Any disorders that would preclude the use of tetracycline-class antibiotics or sarecycline. - Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part in the trial. Other protocol defined Inclusion/Exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
United States | Arlington Research Center | Arlington | Texas |
Lead Sponsor | Collaborator |
---|---|
Angela Moore | Almirall, SAS |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in Acne Severity Based on Investigator's Global Assessment Success | Investigator's Global Assessment (IGA) success for truncal acne vulgaris at week 12 | Baseline, Week 12 | |
Primary | Change from Baseline in Absolute Lesion Count | Absolute change from baseline lesion counts for inflammatory acne for truncal acne vulgaris at week 12 | Baseline, Week 12 | |
Secondary | Adverse Events and Adverse Events of Special Interest | Safety based on adverse events (AEs), adverse events of special interest (AESI), vital signs, and physical examinations | Baseline, Week 12 |
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