Acne VulgarisNCT06186596
Self-Administered Intralesional Injections for Acne
A study testing Triamcinolone delivered via injection assistance device in people with Acne Vulgaris, run by ACOM Labs at 3 sites in United States.
Trial summary
The goal of this clinical trial is to test the safety of intralesional injections of triamcinolone self-administered into acne lesions via an injection assistance device. The main question[s] it aims to answer are: is use of the injection assistance device safe? is delivery of triamcinolone to acne lesions via the… 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 delivered via injection assistance device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2023to 31 Jan 2024
- 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 UPT at Baseline.
- Diagnosed with facial acne vulgaris.
- At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is clinically indicated for standard-of-care intralesional injection(s) of triamcinolone.
- Owner of smartphone with capacity for front-facing photography and app download from Apple App Store or Google Play.
- Able to follow study instructions and likely to comply with virtual follow-up requirements.
- In good general health as determined by medical history at the time of screening (Investigator discretion).
- Sign the IRB-approved ICF (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).
- 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
3 sites in 1 country.
United States3 sites, 2 recruiting
- Recruiting
Skin Care Research
Boca Raton, Florida, 33486
Coordinator
- Recruiting
Center For Dermatology Clinical Research, Inc
Fremont, California, 94538
Coordinator
- Completed
Skin Care Research
Hollywood, Florida, 33021
About this study
Official title: Patient Self-Administered Intralesional Injections of Triamcinolone for Acne Vulgaris
The goal of this clinical trial is to test the safety of intralesional injections of triamcinolone self-administered into acne lesions via an injection assistance device. The main question[s] it aims to answer are:
- is use of the injection assistance device safe?
- is delivery of triamcinolone to acne lesions via the injection assistance device efficacious?
Participants will self-inject low dose triamcinolone into acne lesions and track lesion response via photos and survey for 14 days following injection.
Read the detailed description
This is an open-label, prospective, single-arm study. Approximately 150 subjects will be enrolled at approximately 3 study sites.
All subjects will receive standard-of-care intralesional injection with triamcinolone using an Injection Assistance Device (i.e., for self-administered intralesional injections) at Visit 1 (Day 1). Subjects will then submit photos via secure photographic app for asynchronous follow up on Day 2 (24-hours post-injection), Day 3 (48-hours post-injection), Day 4 (72-hours post-injection), Day 7, and Day 14.
Efficacy assessments (target lesion assessments) will be conducted remotely by the Investigator at time of each photo submission. Subjects will conduct lesion pain assessments and satisfaction assessments at the time of each remote check-in. Participants will be invited to also have additional photography captured by the study team at the study site or at a location as per participants' convenience.
- Conditions
- Acne Vulgaris
- Being tested
- Triamcinolone delivered via injection assistance device
- 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 delivered via injection assistance deviceDevice
0.1mL of 1% to 2% triamcinolone solution will be delivered to up to 3 facial inflammatory acne lesions
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | All subjects will receive standard-of-care intralesional injection with triamcinolone using an Injection Assistance Device (i.e., for self-administered intralesional injections) at Visit 1 (Day 1). Subjects will then submit photos via secure photographic app for asynchronous follow up on Day 2 (24-hours post-injection), Day 3 (48-hours post-injection), Day 4 (72-hours post-injection), Day 7, and Day 14. Receives: Device: Triamcinolone delivered via injection assistance device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events following device use
Adverse events associated with device use for 14 days following injection
Measured: 14 days
Secondary outcomes (7)
Target Lesion Pain
For each inflammatory lesion injected, lesion pain will be assessed by the subject 0 to 10 scale, where 0 is no pain and 10 is worst imaginable pain. Lesion pain at Baseline will be recorded prior to injection(s). The occurrence of inflammatory lesion pain is expected and will not be considered an AE.
Measured: 14 days
Target Lesion Injection Pain
Injection Site Pain during injection will be assessed immediately after the injection of the first target lesion and at 5 minutes post-injection. The occurrence of injection site pain is expected and will not be considered an AE. For each inflammatory lesion injected, lesion pain will be assessed by the subject 0 to 10 scale, where 0 is no pain and 10 is worst imaginable pain.
Measured: baseline and 5 min following injection
Target Lesion Change (subject)
The subject will assess subjective improvement seen with each target lesion compared to Baseline.
- Clear (100%)
- Almost clear (90% to <100%)
- Marked improvement (75% to <90%)
- Moderate improvement (50% to <75%)
- Fair improvement (25% to <50%)
- No change
- Worse
Measured: 24 hours - 14 days
Subject satisfaction or dissatisfaction with treatment assessed via a 5-grade scale
Satisfaction or dissatisfaction with will be assessed by the subject using the following subjective 5-grade scale as detailed below. Subject will be instructed: "Rate your level of satisfaction with the effect of study treatment on inflammatory acne lesions by using the following scale":
- Very satisfied
- Satisfied
- Neither satisfied nor dissatisfied
- Dissatisfied
- Very dissatisfied
Measured: 24 hours - 14 days
Target Lesion Erythema
Investigator will assess severity of erythema for each target lesion on a 0 (no erythema) to 4 (very severe erythema) scale.
0: No Erythema
- Mild Erythema
- Moderate Erythema
- Severe Erythema
- Very Severe Erythema
Measured: baseline - 14 days
Target Lesion Severity
Investigator will assess severity of each target lesion on a 0 (none) to 4 (very severe) scale.
0: None
- Mild
- Moderate
- Severe
- Very Severe
Measured: baseline - 14 days
Target Lesion Change
Investigator will assess improvement of each target lesion on a 1 (100% clear) to 7 (worse) scale.
- Clear (100%)
- Almost clear (90% to <100%)
- Marked improvement (75% to <90%)
- Moderate improvement (50% to <75%)
- Fair improvement (25% to <50%)
- No change
- Worse
Measured: 24 hours - 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Feb 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ACOM Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186596
- Sponsor's protocol ID
- ATM-2301
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 2 Jan 2024
- 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 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Self-Administered Intralesional Injections of Triamcinolone for Acne Vulgaris
- ClinicalTrials.gov ID
- NCT06186596
- Acronym / sponsor ID
- ATM-2301
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- ACOM LabsIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 2 Jan 2024 (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 goal of this clinical trial is to test the safety of intralesional injections of triamcinolone self-administered into acne lesions via an injection assistance device. The main question[s] it aims to answer are:
- is use of the injection assistance device safe?
- is delivery of triamcinolone to acne lesions via the injection assistance device efficacious?
Participants will self-inject low dose triamcinolone into acne lesions and track lesion response via photos and survey for 14 days following injection.
Detailed description
This is an open-label, prospective, single-arm study. Approximately 150 subjects will be enrolled at approximately 3 study sites.
All subjects will receive standard-of-care intralesional injection with triamcinolone using an Injection Assistance Device (i.e., for self-administered intralesional injections) at Visit 1 (Day 1). Subjects will then submit photos via secure photographic app for asynchronous follow up on Day 2 (24-hours post-injection), Day 3 (48-hours post-injection), Day 4 (72-hours post-injection), Day 7, and Day 14.
Efficacy assessments (target lesion assessments) will be conducted remotely by the Investigator at time of each photo submission. Subjects will conduct lesion pain assessments and satisfaction assessments at the time of each remote check-in. Participants will be invited to also have additional photography captured by the study team at the study site or at a location as per participants' convenience.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: Triamcinolone delivered via injection assistance deviceAll subjects will receive standard-of-care intralesional injection with triamcinolone using an Injection Assistance Device (i.e., for self-administered intralesional injections) at Visit 1 (Day 1). Subjects will then submit photos via secure photographic app for asynchronous follow up on Day 2 (24-hours post-injection), Day 3 (48-hours post-injection), Day 4 (72-hours post-injection), Day 7, and Day 14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative UPT at Baseline.
- Diagnosed with facial acne vulgaris.
- At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is clinically indicated for standard-of-care intralesional injection(s) of triamcinolone.
- Owner of smartphone with capacity for front-facing photography and app download from Apple App Store or Google Play.
- Able to follow study instructions and likely to comply with virtual follow-up requirements.
Key exclusion criteria (7 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 delivered via injection assistance device0.1mL of 1% to 2% triamcinolone solution will be delivered to up to 3 facial inflammatory acne lesions | Device | intervention |
Primary outcome
Incidence of adverse events following device use
Time frame: 14 days
Adverse events associated with device use for 14 days following injection
7 secondary outcomes
Target Lesion Pain
Time frame: 14 days
Target Lesion Injection Pain
Time frame: baseline and 5 min following injection
Target Lesion Change (subject)
Time frame: 24 hours - 14 days
Subject satisfaction or dissatisfaction with treatment assessed via a 5-grade scale
Time frame: 24 hours - 14 days
Target Lesion Erythema
Time frame: baseline - 14 days
Target Lesion Severity
Time frame: baseline - 14 days
Target Lesion Change
Time frame: 24 hours - 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone delivered via injection assistance device in people with Acne Vulgaris, run by ACOM Labs at 3 sites 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lyra Olson, PhD (5142096452, lolson@atomic.vc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events following device use (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 2 Jan 2024.