Sarecycline Truncal Acne Safety and Efficacy Response (TASER)

July 29, 2023 updated by: Angela Moore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with moderate to severe truncal acne at a single center in Texas, USA.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Week 12
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
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angela Moore

Collaborators

Almirall, SAS

Investigators

  • Principal Investigator: Angela Moore, MD, Arlington Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2021

Primary Completion (Actual)

June 24, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 29, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sarecycline TASER1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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