Sarecycline Truncal Acne Safety and Efficacy Response

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Sarecycline

• Registration Number: NCT05010538
• Lead Sponsor: Angela Moore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-09
• Primary Completion: 2021-06-24
• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-18
• Study Completion: 2021-08-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-29
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sarecycline	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Acne Severity Based on Investigator's Global Assessment Success	Baseline, Week 12	Investigator's Global Assessment (IGA) success for truncal acne vulgaris at week 12
Change from Baseline in Absolute Lesion Count	Baseline, Week 12	Absolute change from baseline lesion counts for inflammatory acne for truncal acne vulgaris at week 12

Secondary Outcome Measures

Name	Time	Method
Adverse Events and Adverse Events of Special Interest	Baseline, Week 12	Safety based on adverse events (AEs), adverse events of special interest (AESI), vital signs, and physical examinations

Trial Locations

Locations (1)

Arlington Research Center; 🇺🇸 Arlington, Texas, United States