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NCT03303170 Clinical Trial

Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:
A Prospective, Multicenter, Randomized, Controlled, Evaluator-Blinded Study of the Safety and Effectiveness of Sebacia Microparticles as an Accessory to 1064 nm Nd:Yag Laser in the Treatment of Facial Inflammatory Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03303170
Other study ID # SEB-0493
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 25, 2017
Est. completion date April 10, 2018

Study information
Verified date October 2019
Source Sebacia, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective, randomized, controlled, parallel group clinical study with blinded assessment evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris

Recruitment information / eligibility
Status Completed
Enrollment 168
Est. completion date April 10, 2018
Est. primary completion date April 10, 2018
Accepts healthy volunteers No
Gender All
Age group 12 Years to 45 Years
Eligibility Inclusion Criteria:

- Mild to moderate acne vulgaris

- At least 15 inflammatory acne lesions

- Skin phototype I - III

- Able to understand and comply with study requirements

Exclusion Criteria:

- Severe acne vulgaris

- Nodulocystic acne

- Ongoing use of medications and/or treatments for acne

- New hormone regimen (used for less than 12 weeks)

- Significant medical or mental health condition

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Sebacia Microparticles
Topical microparticle suspension
• Nd:Yag Laser
Laser delivering 1064 nm wavelength light

Locations
Country Name City State
United States Austin Institute for Clinical Research Austin Texas
United States Dermatology, Laser & Vein Institute Charlotte North Carolina
United States The Center for Skin Research Katy Texas
United States Miami Dermatology & Laser Institute Miami Florida
United States International Clinical Research Murfreesboro Tennessee
United States Wake Research Associates Raleigh North Carolina
United States MediSearch Clinical Trials Saint Joseph Missouri
United States Scripps Health San Diego California
United States Meridian Clinical Research Savannah Georgia
United States Clear Dermatology & Aesthetics Center Scottsdale Arizona
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 Change in number of inflammatory acne lesions Week 12
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