An observational study in Acne Vulgaris, sponsored by Angela Moore. Completed at 1 site in United States. Open to participants aged 9 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Angela Moore · 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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 10 is below the median of 90 across 81 observational studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →This is the only study on the registry with Angela Moore as lead sponsor.
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Patients with moderate to severe truncal acne at a single center in Texas, USA.
Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
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.
Drug: Sarecycline
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.
Also known as: Seysara®
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
Time frame: 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
Time frame: Baseline, Week 12
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
Time frame: Baseline, Week 12
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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