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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05010538
Other study ID # Sarecycline TASER1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 9, 2021
Est. completion date August 31, 2021

Study information

Verified date July 2023
Source Arlington Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date August 31, 2021
Est. primary completion date June 24, 2021
Accepts healthy volunteers
Gender All
Age group 9 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Arlington Research Center Arlington Texas

Sponsors (2)

Lead Sponsor Collaborator
Angela Moore Almirall, SAS

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Acne Severity Based on Investigator's Global Assessment Success Investigator's Global Assessment (IGA) success for truncal acne vulgaris at week 12 Baseline, Week 12
Primary Change from Baseline in Absolute Lesion Count Absolute change from baseline lesion counts for inflammatory acne for truncal acne vulgaris at week 12 Baseline, Week 12
Secondary Adverse Events and Adverse Events of Special Interest Safety based on adverse events (AEs), adverse events of special interest (AESI), vital signs, and physical examinations Baseline, Week 12
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