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NCT03818555 Clinical Trial

Sebacia Postmarket Study of Real-World Use

Acne Vulgaris Clinical Trial

Official title:
A Prospective, Multicenter, Postmarket Study of Sebacia Microparticles Treatment in Patients Using Topical Acne Products for Mild to Moderate Inflammatory Acne Vulgaris

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03818555
Other study ID # SEB-0550
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date June 2021

Study information
Verified date October 2020
Source Sebacia, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 125
Est. completion date June 2021
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years to 45 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Sebacia Microparticles Treatment
Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.

Locations
Country Name City State
United States Austin Institute for Clinical Research - Central Austin Texas
United States Dermatology Institute of Boston Boston Massachusetts
United States Miami Dermatology & Laser Institute Miami Florida
United States International Clinical Research Murfreesboro Tennessee
United States Austin Institute for Clinical Research - Pflugerville Pflugerville Texas
United States Premier Clinical Research Spokane Washington

Sponsors (1)
Lead Sponsor Collaborator
Sebacia, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Inflammatory Lesion Count Percent change in number of inflammatory lesions from baseline Months 2, 3, 6, 9 and 12
Secondary Investigator's Global Assessment Percent of subjects clear (IGA 0) or almost clear (IGA 1) Months 2, 3, 6, 9 and 12
Secondary Physician's Overall Assessment of Improvement Categorical improvement from baseline (worse, no change, minimal, moderate, marked, complete) Months 2, 3, 6, 9 and 12
See also
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Completed NCT03303170 - Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris N/A
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