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Sarecycline Truncal Acne Safety and Efficacy Response (TASER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05010538
Recruitment Status : Active, not recruiting
First Posted : August 18, 2021
Last Update Posted : August 20, 2021
Sponsor:
Collaborator:
Almirall, SAS
Information provided by (Responsible Party):
Angela Moore, Arlington Research Center

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
Acne Vulgaris Drug: Sarecycline

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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 : March 9, 2021
Actual Primary Completion Date : June 24, 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Group/Cohort 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 Name: Seysara®




Primary Outcome Measures :
  1. Change from Baseline in Acne Severity Based on Investigator's Global Assessment Success [ Time Frame: Baseline, Week 12 ]
    Investigator's Global Assessment (IGA) success for truncal acne vulgaris at week 12

  2. Change from Baseline in Absolute Lesion Count [ Time Frame: Baseline, Week 12 ]
    Absolute change from baseline lesion counts for inflammatory acne for truncal acne vulgaris at week 12


Secondary Outcome Measures :
  1. Adverse Events and Adverse Events of Special Interest [ Time Frame: Baseline, Week 12 ]
    Safety based on adverse events (AEs), adverse events of special interest (AESI), vital signs, and physical examinations



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with moderate to severe truncal acne at a single center in Texas, USA.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05010538


Locations
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United States, Texas
Arlington Research Center
Arlington, Texas, United States, 76011
Sponsors and Collaborators
Angela Moore
Almirall, SAS
Investigators
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Principal Investigator: Angela Moore, MD Arlington Research Center
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Responsible Party: Angela Moore, Principal Investigator, Arlington Research Center
ClinicalTrials.gov Identifier: NCT05010538    
Other Study ID Numbers: Sarecycline TASER1
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Angela Moore, Arlington Research Center:
Acne Vulgaris
Sarecycline
Tetracycline
Truncal Acne
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Sarecycline
Anti-Bacterial Agents
Anti-Infective Agents
Dermatologic Agents