Acne VulgarisTASERNCT05010538
Sarecycline Truncal Acne Safety and Efficacy Response
An observational study of Acne Vulgaris, run by Angela Moore at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 50 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Sarecycline
- Type of treatment
- Pill or oral medicine
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2021to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 50 years
- All sexes
- Child, Adult
Study population: Patients with moderate to severe truncal acne at a single center in Texas, USA.
Who may be able to join
- Male or female age 9 or above.
- Clinical diagnosis of moderate to severe truncal acne based on IGA
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Acne Vulgaris
- Being tested
- Sarecycline
- Keywords
- Acne Vulgaris, Sarecycline, Tetracycline, Truncal Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SarecyclineDrug
Also called Seysara®
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sarecycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Week 12
Change from Baseline in Absolute Lesion Count
Absolute change from baseline lesion counts for inflammatory acne for truncal acne vulgaris at week 12
Measured: Baseline, Week 12
Secondary outcomes (1)
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
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start9 Mar 2021
- Primary completion24 Jun 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angela Moore
- Sponsor type
- University, hospital or other
- Collaborators
- Almirall, SAS
- Responsible party
- Sponsor-investigator, Angela Moore, Arlington Research Center
- Investigators
- Angela Moore, MD, Principal investigator, Arlington Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010538
- Sponsor's protocol ID
- Sarecycline TASER1
- Acronym
- TASER
- Status last verified
- Jul 2023
- First submitted
- 11 Aug 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05010538
- Acronym / sponsor ID
- TASER / Sarecycline TASER1
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Sarecycline, Tetracycline, Truncal Acne
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Angela MooreUniversity, hospital or other
- Collaborators
- Almirall, SAS
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sarecycline | – | Drug: SarecyclineEligible 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. |
Who may qualify
- Ages
- 9 to 50 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients with moderate to severe truncal acne at a single center in Texas, USA.
Key inclusion criteria (2 listed)
- Male or female age 9 or above.
- Clinical diagnosis of moderate to severe truncal acne based on IGA
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SarecyclineAlso: Seysara®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. | Drug | Sarecycline |
Primary outcome
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
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
1 secondary outcome
Adverse Events and Adverse Events of Special Interest
Time frame: Baseline, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Moore, MD principal investigator
Arlington Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Angela Moore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Acne Severity Based on Investigator's Global Assessment Success (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.