NCT05010538

Sarecycline Truncal Acne Safety and Efficacy Response

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Angela Moore · Academic / Other
• Sex: All
• Age: 9 Years – 50 Years
• Healthy volunteers: —

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-09
• Primary completion: 2021-06-24
• Completion: 2021-08-31
• First posted: 2021-08-18
• Last updated: 2023-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study