Last updated: December 6, 2023
Sponsor: ACOM Labs
Overall Status: Completed
Phase
N/A
Condition
Rash
Acne
Inflammatory Comedones
Treatment
Triamcinolone Injection
Clinical Study ID
NCT06170593
ATM-2201
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Outpatient, male or female of any race, 18 years of age or older. Female subjects ofchildbearing 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 theinvestigator, 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 toany study-related procedures being performed
Exclusion
Exclusion Criteria:
- Female subjects who are pregnant or breast-feeding.
- Known hypersensitivity or previous allergic reaction to any constituent oftriamcinolone injection.
- Active cutaneous viral infection in any treatment area at Baseline.
- Have concomitant skin disease or infection (other than acne) or presence of skincomorbidities 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 suchemployees.
- Exposure to any other investigational /device within 30 days prior to Visit 1.
Study Design
Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Triamcinolone Injection
Phase:
Study Start date:
November 15, 2022
Estimated Completion Date:
February 14, 2023
Study Description
Connect with a study center
Center For Dermatology Clinical Research, Inc
Fremont, California 94538
United StatesSite Not Available
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