Sarecycline Truncal Acne Safety and Efficacy Response

NCT ID: NCT05010538

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-09

Study Completion Date

2021-08-31

Brief Summary

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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

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Conditions

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Acne Vulgaris

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Sarecycline

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Seysara®

Eligibility Criteria

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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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Almirall, SAS

INDUSTRY

Sponsor Role collaborator

Angela Moore

OTHER

Sponsor Role lead

Responsible Party

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Angela Moore

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Angela Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Arlington Research Center

Locations

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Arlington Research Center

Arlington, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Sarecycline TASER1

Identifier Type: -

Identifier Source: org_study_id

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