Sarecycline Truncal Acne Safety and Efficacy Response | NCT05010538 | Trialant

Sarecycline Truncal Acne Safety and Efficacy Response | NCT05010538 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Sarecycline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sarecycline	Drug	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Contacts/Locations Module

Condition Browse Module