Sebacia Postmarket Study of Real-World Use

Sebacia

Status: Unknown

Conditions: Acne Vulgaris

Treatments: Other: Sebacia Microparticles Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03818555

SEB-0550

Details and patient eligibility

About

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

Enrollment: 125 estimated patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

Sebacia Microparticles Treatment

Other group

Treatment:

Other: Sebacia Microparticles Treatment