Sarecycline Truncal Acne Safety and Efficacy Response

Study Overview
=================
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.

Official 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

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Sarecycline


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sarecycline<br>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<br>* 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.<br>* Other names: Seysara®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne Vulgaris, Sarecycline, Tetracycline, Truncal Acne