Acne VulgarisATM-2201NCT06170593
Intralesional Injections of Triamcinolone for Acne Vulgaris
A study testing Triamcinolone Injection in people with Acne Vulgaris, run by ACOM Labs at 1 site in United States.
Trial summary
This proof-of-concept study seeks to investigate the safety of intralesional injections of triamcinolone for acne vulgaris lesions using an Intradermal Needle Adapter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Triamcinolone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 14 Feb 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline.
- Diagnosed with facial acne vulgaris.
- At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is amenable to intralesional injection of triamcinolone.
- Able to follow study instructions and likely to complete all required visits.
- In good general health as determined by medical history at the time of screening (Investigator discretion).
- Sign the IRB-approved informed consent form (including HIPAA authorization) prior to any study-related procedures being performed
Who cannot join
- Female subjects who are pregnant or breast-feeding.
- Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone injection.
- Active cutaneous viral infection in any treatment area at Baseline.
- Have concomitant skin disease or infection (other than acne) or presence of skin comorbidities in the areas of skin where study device will be used.
- History of poor cooperation or unreliability (Investigator discretion).
- Planning to move out of the area prior to study completion.
- Subjects who are investigational site staff members or family members of such employees.
- Exposure to any other investigational /device within 30 days prior to Visit 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center For Dermatology Clinical Research, Inc
Fremont, California, 94538
About this study
This proof-of-concept study seeks to investigate the safety of intralesional injections of triamcinolone for acne vulgaris lesions using an Intradermal Needle Adapter.
Read the detailed description
This is an open-label, prospective, single-arm study. Approximately 20 subjects will be enrolled at 1 study site.
All subjects will receive treatment with the study protocol (i.e., intralesional injection with triamcinolone) at Visit 1 (Day 1). Subjects will then attend in-clinic visits at Visit 2 (24-hours post-injection), Visit 3 (48-hours post-injection), Visit 4 (72-hours post-injection), Visit 5 (Day 7), and Visit 6 (Day 14).
Efficacy assessments (target lesion assessments, photography) and safety assessments will be conducted by the Investigator at each study visit. Subjects will conduct lesion pain assessments at each study visit as well as satisfaction assessments at each post-treatment visit.
- Conditions
- Acne Vulgaris
- Being tested
- Triamcinolone Injection
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone InjectionDrug
0.1mL of triamcinolone 1% solution per lesion
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Participants will receive injections of 1% triamcinolone into at least 1 and up to 3 facial inflammatory acne lesions. Participants will return to clinic at 24, 48, 72 hours, 7 days, and 14 days following injection for follow up assessment and photography. Receives: Drug: Triamcinolone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of intralesional triamcinolone injection
Adverse events and changes in concomitant medications
Measured: 14 days
Secondary outcomes (5)
Target Lesion Erythema
A 5-point scale ranging from 0 (No Erythema) to 4 (Very Severe Erythema).
Measured: 14 days
Target Lesion Severity
A 5-point scale ranging from 0 (None) to 4 (Very Severe)
Measured: 14 days
Target Lesion Improvement
A 7-point scale ranging from 1 (Clear; 100%) to 7 (Worse)
Measured: 14 days
Target Lesion Pain
0-10 Visual Analog Scale
Measured: 14 days
Target Lesion Injection Pain
0-10 Visual Analog Scale
Measured: Immediately after the injection of the first target lesion and at 5 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start15 Nov 2022
- Primary completion31 Jan 2023
- Study completion14 Feb 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACOM Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170593
- Sponsor's protocol ID
- ATM-2201
- Acronym
- ATM-2201
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Injections of Triamcinolone for Acne Vulgaris
- ClinicalTrials.gov ID
- NCT06170593
- Acronym / sponsor ID
- ATM-2201 / ATM-2201
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ACOM LabsIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 14 Dec 2023 (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.
This proof-of-concept study seeks to investigate the safety of intralesional injections of triamcinolone for acne vulgaris lesions using an Intradermal Needle Adapter.
Detailed description
This is an open-label, prospective, single-arm study. Approximately 20 subjects will be enrolled at 1 study site.
All subjects will receive treatment with the study protocol (i.e., intralesional injection with triamcinolone) at Visit 1 (Day 1). Subjects will then attend in-clinic visits at Visit 2 (24-hours post-injection), Visit 3 (48-hours post-injection), Visit 4 (72-hours post-injection), Visit 5 (Day 7), and Visit 6 (Day 14).
Efficacy assessments (target lesion assessments, photography) and safety assessments will be conducted by the Investigator at each study visit. Subjects will conduct lesion pain assessments at each study visit as well as satisfaction assessments at each post-treatment visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Triamcinolone InjectionParticipants will receive injections of 1% triamcinolone into at least 1 and up to 3 facial inflammatory acne lesions. Participants will return to clinic at 24, 48, 72 hours, 7 days, and 14 days following injection for follow up assessment and photography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline.
- Diagnosed with facial acne vulgaris.
- At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is amenable to intralesional injection of triamcinolone.
- Able to follow study instructions and likely to complete all required visits.
- In good general health as determined by medical history at the time of screening (Investigator discretion).
Key exclusion criteria (8 listed)
- Female subjects who are pregnant or breast-feeding.
- Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone injection.
- Active cutaneous viral infection in any treatment area at Baseline.
- Have concomitant skin disease or infection (other than acne) or presence of skin comorbidities in the areas of skin where study device will be used.
- History of poor cooperation or unreliability (Investigator discretion).
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 |
|---|---|---|
| Triamcinolone Injection0.1mL of triamcinolone 1% solution per lesion | Drug | Treatment group |
Primary outcome
Safety of intralesional triamcinolone injection
Time frame: 14 days
Adverse events and changes in concomitant medications
5 secondary outcomes
Target Lesion Erythema
Time frame: 14 days
Target Lesion Severity
Time frame: 14 days
Target Lesion Improvement
Time frame: 14 days
Target Lesion Pain
Time frame: 14 days
Target Lesion Injection Pain
Time frame: Immediately after the injection of the first target lesion and at 5 minutes post-injection
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 14 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone Injection in people with Acne Vulgaris, run by ACOM Labs 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 6 inclusion and 8 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 14 Dec 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?
Safety of intralesional triamcinolone injection (time frame: 14 days). 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 14 Dec 2023.