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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05010538

Acronym

TASER

Enrollment

Registered

2021-08-18

Start date

2021-03-09

Completion date

2021-08-31

Last updated

2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris, Sarecycline, Tetracycline, Truncal Acne

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.

Interventions

DRUGSarecycline

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Years to 50 Years

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/

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026