Sarecycline Truncal Acne Safety and Efficacy Response

Acne Vulgaris Clinical Trial

— TASER  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05010538
• Other study ID #: Sarecycline TASER1
• Status: Completed
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Acne Vulgaris

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