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Completed

NCT Number: NCT05010538

Sarecycline Truncal Acne Safety and Efficacy Response

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

9 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arlington Research Center

Arlington, Texas, 76011, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Seysara®

Primary outcomes

  1. Change from Baseline in Acne Severity Based on Investigator's Global Assessment Success

    Time frame: Baseline, Week 12

    Investigator's Global Assessment (IGA) success for truncal acne vulgaris at week 12

  2. Change from Baseline in Absolute Lesion Count

    Time frame: Baseline, Week 12

    Absolute change from baseline lesion counts for inflammatory acne for truncal acne vulgaris at week 12

Secondary outcomes

  1. Adverse Events and Adverse Events of Special Interest

    Time frame: Baseline, Week 12

    Safety based on adverse events (AEs), adverse events of special interest (AESI), vital signs, and physical examinations

Sponsors and collaborators

Lead sponsor

Angela Moore

Other

Collaborators

  • Almirall, SAS

Registry information

Official study 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

Acronym: TASER

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 18, 2021
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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