Intralesional Injections of Triamcinolone for Acne Vulgaris

NCT ID: NCT06170593

Last Updated: 2023-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2023-02-14

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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.

Group Type: EXPERIMENTAL

Triamcinolone Injection

Intervention Type: DRUG

0.1mL of triamcinolone 1% solution per lesion

Interventions

Triamcinolone Injection

0.1mL of triamcinolone 1% solution per lesion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ACOM Labs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center For Dermatology Clinical Research, Inc

Fremont, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ATM-2201

Identifier Type: -

Identifier Source: org_study_id