Intralesional Injections of Triamcinolone for Acne Vulgaris

NCT06170593 | Completed

• 1 other identifier: ATM-2201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Safety of intralesional triamcinolone injection

  Adverse events and changes in concomitant medications

  14 days

Secondary Outcomes (5)

• Target Lesion Erythema

  14 days

• Target Lesion Severity

  14 days

• Target Lesion Improvement

  14 days

• Target Lesion Pain

  14 days

• Target Lesion Injection Pain

  Immediately after the injection of the first target lesion and at 5 minutes post-injection

Study Arms (1)

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.

Drug: Triamcinolone Injection

Interventions

Triamcinolone Injection DRUG

0.1mL of triamcinolone 1% solution per lesion

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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

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).
• 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.

Sponsors & Collaborators

• ACOM Labs: lead

Study Sites (1)

Center For Dermatology Clinical Research, Inc

Fremont, California, 94538, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

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 6, 2023
• First Posted: December 14, 2023
• Study Start: November 15, 2022
• Primary Completion: January 31, 2023
• Study Completion: February 14, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)