A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris

Sebacia

Status: Completed

Conditions: Facial Acne Vulgaris

Treatments: Device: Sebacia Microparticles

Study type: Interventional

Funder types: Industry

Identifiers

NCT02758041

SEB-0294CH, SEB-0400

Details and patient eligibility

About

This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory acne vulgaris.

Enrollment: 85 patients

Sex: All

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, 16-45 years of age.
2. Moderate to moderately-severe facial inflammatory acne vulgaris
3. Fitzpatrick skin phototype I-III

Exclusion criteria

1. Pregnant, lactating, nursing or planning to become pregnant
2. Tattoo in the treatment area
3. Active skin disease, excessive scarring or excess facial hair in the treatment area
4. Certain current or recent acne treatments
5. Recent light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area
6. Contraindicated for laser treatment, or is unable or unwilling to avoid excessive sun exposure or tanning bed use
7. Known allergy to gold

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Sebacia Microparticles

Experimental group

Treatment:

Device: Sebacia Microparticles