Self-Administered Intralesional Injections for Acne

NCT ID: NCT06186596

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-01-31

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.

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

Study Design

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

Study Groups

intervention

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.

Group Type: EXPERIMENTAL

Triamcinolone delivered via injection assistance device

Intervention Type: DEVICE

0.1mL of 1% to 2% triamcinolone solution will be delivered to up to 3 facial inflammatory acne lesions

Interventions

Triamcinolone delivered via injection assistance device

0.1mL of 1% to 2% triamcinolone solution will be delivered to up to 3 facial inflammatory acne lesions

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Diagnosed with facial acne vulgaris.

3. 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.

4. Owner of smartphone with capacity for front-facing photography and app download from Apple App Store or Google Play.

5. Able to follow study instructions and likely to comply with virtual follow-up requirements.

6. In good general health as determined by medical history at the time of screening (Investigator discretion).

7. Sign the IRB-approved ICF (including HIPAA authorization) prior to any study-related procedures being performed.

Exclusion Criteria

1. Female subjects who are pregnant or breast-feeding.

2. Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone injection.

3. Active cutaneous viral infection in any treatment area at Baseline.

4. 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.

5. History of poor cooperation or unreliability (Investigator discretion).

6. Subjects who are investigational site staff members or family members of such employees.

7. 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

Site Status: RECRUITING

Skin Care Research

Boca Raton, Florida, United States

Site Status: RECRUITING

Skin Care Research

Hollywood, Florida, United States

Site Status: COMPLETED

Countries

United States

Central Contacts

Lyra Olson, PhD

Role: CONTACT

lolson@atomic.vc

5142096452

Facility Contacts

Coordinator

Role: primary

Coordinator

Role: primary

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ATM-2301

Identifier Type: -

Identifier Source: org_study_id