Intralesional Injections of Triamcinolone for Acne Vulgaris

Acne Vulgaris Clinical Trial

— ATM-2201  

Official title:

Intralesional Injections of Triamcinolone for Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06170593
• Other study ID #: ATM-2201
• Status: Completed
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: February 14, 2023

Study information

• Verified date: December 2023
• Source: ACOM Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 14, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Triamcinolone Injection
0.1mL of triamcinolone 1% solution per lesion

Locations

Country	Name	City	State
United States	Center For Dermatology Clinical Research, Inc	Fremont	California

Sponsors (1)

Lead Sponsor	Collaborator
ACOM Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of intralesional triamcinolone injection	Adverse events and changes in concomitant medications	14 days
Secondary	Target Lesion Erythema	A 5-point scale ranging from 0 (No Erythema) to 4 (Very Severe Erythema).	14 days
Secondary	Target Lesion Severity	A 5-point scale ranging from 0 (None) to 4 (Very Severe)	14 days
Secondary	Target Lesion Improvement	A 7-point scale ranging from 1 (Clear; 100%) to 7 (Worse)	14 days
Secondary	Target Lesion Pain	0-10 Visual Analog Scale	14 days
Secondary	Target Lesion Injection Pain	0-10 Visual Analog Scale	Immediately after the injection of the first target lesion and at 5 minutes post-injection