TASER: Sarecycline Truncal Acne Safety and Efficacy Response

Sponsor

Angela Moore (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05010538

Collaborator

Almirall, SAS (Industry)

Enrollment

Location

6.8

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Sarecycline

Study Design

Study Type:

Observational

Actual Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Mar 9, 2021

Actual Primary Completion Date :

Jun 24, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	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®

Arm

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®

Outcome Measures

Primary Outcome Measures

Change from Baseline in Acne Severity Based on Investigator's Global Assessment Success [Baseline, Week 12]
Investigator's Global Assessment (IGA) success for truncal acne vulgaris at week 12
Change from Baseline in Absolute Lesion Count [Baseline, Week 12]
Absolute change from baseline lesion counts for inflammatory acne for truncal acne vulgaris at week 12

Secondary Outcome Measures

Adverse Events and Adverse Events of Special Interest [Baseline, Week 12]
Safety based on adverse events (AEs), adverse events of special interest (AESI), vital signs, and physical examinations

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arlington Research Center	Arlington	Texas	United States	76011

Sponsors and Collaborators

Angela Moore
Almirall, SAS

Investigators

Principal Investigator: Angela Moore, MD, Arlington Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Angela Moore, Principal Investigator, Arlington Research Center

ClinicalTrials.gov Identifier:

NCT05010538

Other Study ID Numbers:

Sarecycline TASER1

First Posted:

Aug 18, 2021

Last Update Posted:

Aug 20, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Angela Moore, Principal Investigator, Arlington Research Center

Additional relevant MeSH terms:

Acne Vulgaris

Sarecycline

Study Results

No Results Posted as of Aug 20, 2021