Status:
UNKNOWN
Sebacia Postmarket Study of Real-World Use
Lead Sponsor:
Sebacia, Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12-45 years
Phase:
NA
Brief Summary
Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.
Eligibility Criteria
Inclusion
- Mild to moderate facial inflammatory acne vulgaris (IGA 2 or 3)
- Between 10 and 50 papules/pustules
- Fitzpatrick skin phototype I, II or III
- Able to provide informed consent and comply with study schedule and other requirements
Exclusion
- Moderately severe or severe acne vulgaris (IGA 4 or 5)
- Nodulocystic acne, significant scarring or excoriation
- Requires oral retinoid, antibiotic or corticosteroid for acne
- New or fluctuating hormone or hormone-regulating therapy
- Photosensitivity or allergy to gold
- Medical or mental health condition that would pose a risk to patient or impair treatment and evaluation
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT03818555
Start Date
January 1 2019
End Date
June 1 2021
Last Update
October 27 2020
Active Locations (6)
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1
Miami Dermatology & Laser Institute
Miami, Florida, United States, 33173
2
Dermatology Institute of Boston
Boston, Massachusetts, United States, 02116
3
International Clinical Research
Murfreesboro, Tennessee, United States, 37130
4
Austin Institute for Clinical Research - Central
Austin, Texas, United States, 78705