NCT06186596

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

12 months

First QC Date

December 5, 2023

Last Update Submit

December 15, 2023

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events following device use

    Adverse events associated with device use for 14 days following injection

    14 days

Secondary Outcomes (7)

  • Target Lesion Pain

    14 days

  • Target Lesion Injection Pain

    baseline and 5 min following injection

  • Target Lesion Change (subject)

    24 hours - 14 days

  • Subject satisfaction or dissatisfaction with treatment assessed via a 5-grade scale

    24 hours - 14 days

  • Target Lesion Erythema

    baseline - 14 days

  • +2 more secondary outcomes

Study Arms (1)

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.

Device: Triamcinolone delivered via injection assistance device

Interventions

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

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Center For Dermatology Clinical Research, Inc

Fremont, California, 94538, United States

RECRUITING

Skin Care Research

Boca Raton, Florida, 33486, United States

RECRUITING

Skin Care Research

Hollywood, Florida, 33021, United States

COMPLETED

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Central Study Contacts

Lyra Olson, PhD

CONTACT

5142096452lolson@atomic.vc

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2023

First Posted

January 2, 2024

Study Start

February 1, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(3)