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Sarecycline Truncal Acne Safety and Efficacy Response

NCT05010538 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2023-08-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Almirall, SAS

    collaborator INDUSTRY

  • Angela Moore

    lead OTHER

Principal Investigators

  • Angela Moore, MD · Arlington Research Center

Eligibility

Min Age
9 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2021-06-24
Completion
2021-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05010538 on ClinicalTrials.gov