Sarecycline Truncal Acne Safety and Efficacy Response
TASER
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
1 other identifier
observational
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2021
CompletedFirst Submitted
Initial submission to the registry
August 11, 2021
CompletedFirst Posted
Study publicly available on registry
August 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedAugust 1, 2023
July 1, 2023
4 months
August 11, 2021
July 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Adverse Events and Adverse Events of Special Interest
Baseline, Week 12
Study Arms (1)
Sarecycline
Eligible patients will be prescribed with commercially available sarecycline at a dosage of 1.5 mg/kg/day and followed for 12 weeks post initiation of treatment.
Interventions
60 mg sarecycline tablets will be given for subjects with a body weight of 33 to 54 kg, 100 mg sarecycline tablets will be given for subjects with a body weight of 55 to 84 kg, and 150 mg tablets will be given for subjects with a body weight between 85 and 136 kg.
Eligibility Criteria
Patients with moderate to severe truncal acne at a single center in Texas, USA.
You may qualify if:
- Male or female age 9 or above.
- Clinical diagnosis of moderate to severe truncal acne based on IGA
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Angela Moorelead
- Almirall, SAScollaborator
Study Sites (1)
Arlington Research Center
Arlington, Texas, 76011, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela Moore, MD
Arlington Research Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 11, 2021
First Posted
August 18, 2021
Study Start
March 9, 2021
Primary Completion
June 24, 2021
Study Completion
August 31, 2021
Last Updated
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share