Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

Inflammatory Acne Vulgaris Clinical Trial

Official title:

A Randomized, Prospective, Multicenter, Controlled Study With Blinded Assessment to Determine the Safety and Effectiveness of the Sebacia Acne Treatment System in the Treatment of Inflammatory Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217228
• Other study ID #: SEB-0121
• Secondary ID: IDE #G120273
• Status: Completed
• Phase: N/A
• First received: August 11, 2014
• Last updated: September 8, 2017
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2017
• Source: Sebacia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, randomized multicenter study to examine the safety and effectiveness of Sebacia microparticles with or without laser in the treatment of moderate to moderately-severe inflammatory acne vulgaris

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

Inclusion Criteria:

• Males and females, 15 - 45 years of age

• Able to provide informed consent/assent; minors will provide assent while parent or legal guardian will provide consent

• Moderate to moderately severe (3 or 4) inflammatory acne vulgaris by Investigator's Global Assessment

• Subject has 25 to 75 inflammatory lesions on the cheeks, chin and forehead, not concentrated in one area

• Subject has Fitzpatrick skin phototype I, II or III

• Subject is in good health, willing to participate and able to comply with protocol requirements

Exclusion Criteria:

• Severe acne (Investigator's Global Assessment 5) with significant scarring potential and greater than 2 nodular lesions

• Clinically relevant history of keloids

• Facial tattoos

• Acne conglobata, acne fulminans, chloracne, drug-induced acne

• Active concomitant skin disease, excessive scarring or excess facial hair

• Heavily tanned skin; unable or unwilling to avoid tanning beds/excessive sun exposure

• Acne medication and therapy restrictions - time period prior to Baseline (below)

1. Oral retinoids - 6 months

2. Other systemic medications - 4 weeks

3. Topical retinoids, steroids, antibiotics - 2 weeks

4. OTC topical treatments - 1 week

5. Light treatments (including IPL or laser), microdermabrasion and/or peels - 8 weeks

6. Investigational drug, biologic or device - 30 days

7. Gold therapy of any type for any reason - EXCLUDED

• Pregnant, lactating, nursing or planning to become pregnant during the study period

• Known allergy to gold, ethanol, diisopropyl adipate, Polysorbate 80

• Clinically relevant condition that makes participation unsafe or that would interfere with study treatment and assessment

Related Conditions & MeSH terms

• Acne Vulgaris
• Inflammatory Acne Vulgaris

Intervention

Device:
• Sebacia microparticles and laser

• Vehicle suspension and laser

• Sebacia microparticles without laser

Locations

Country	Name	City	State
United States	Shideler Clinical Research Center	Carmel	Indiana
United States	Dermatology & Laser Center of Charleston	Charleston	South Carolina
United States	Dermatology, Laser & Vein Specialists of the Carolinas	Charlotte	North Carolina
United States	Clarkston Skin Research	Clarkston	Michigan
United States	Skin Laser & Surgery Specialists of NY & NJ	Hackensack	New Jersey
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Maryland Laser, Skin & Vein Institute	Hunt Valley	Maryland
United States	James Q Del Rosso, DO, LLC	Las Vegas	Nevada
United States	Miami Dermatology & Laser Institute	Miami	Florida
United States	The Dermatology Institute-DuPage Medical Group	Naperville	Illinois
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	Center for Dermatology & Laser Surgery	Sacramento	California
United States	Laser & Skin Surgery Center of Northern California	Sacramento	California
United States	Spencer Dermatology	Saint Petersburg	Florida
United States	Clear Dermatology & Aesthetics Center	Scottsdale	Arizona
United States	Gwinnett Dermatology, PC	Snellville	Georgia
United States	Spokane Dermatology Clinic	Spokane	Washington
United States	Yardley Dermatology Associates	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sebacia, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent change in inflammatory lesion count from Baseline to Week 12		Week 12
Primary	Number of of adverse events		Screening to 12 Weeks
Secondary	Mean absolute change in inflammatory lesion count from Baseline to Week 12		Week 12
Secondary	Success by Investigator's Global Assessment at Week 12 (defined as 2-point decrease from Baseline IGA)		Week 12

External Links

•   Sebacia Acne Study Website