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

N/ACompletedNCT02758041

Sebacia, Inc.85 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Facial Acne Vulgaris

Interventions

Sebacia MicroparticlesDEVICE

Eligibility

Sex: ALLMin age: 16 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (3)

Lasercenter North

Aalborg, Denmark

Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen

Copenhagen, Denmark

SKINPULSE Dermatology Laser & Beauty Center

Geneva, Switzerland

Outcomes

Primary Outcomes

Percent reduction in lesion count from baseline

Time frame: Baseline, Week 12, Week 24, Week 36

Secondary Outcomes

Improvement in Investigator Global Acne Score

Time frame: Baseline, Week 12, Week 24, Week 36

Data from ClinicalTrials.gov

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