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

Sponsor
Sebacia, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03303170
Collaborator
(none)
168
Enrollment
11
Locations
2
Arms
6.5
Actual Duration (Months)
15.3
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Sebacia Microparticles
  • Device: Nd:Yag Laser
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 25, 2017
Actual Primary Completion Date :
Apr 10, 2018
Actual Study Completion Date :
Apr 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sebacia Microparticles

Device: Sebacia Microparticles
Topical microparticle suspension
Active Comparator: Nd:Yag Laser

Device: Nd:Yag Laser
Laser delivering 1064 nm wavelength light

Outcome Measures

Primary Outcome Measures

  1. Change in number of inflammatory acne lesions [Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clear Dermatology & Aesthetics Center Scottsdale Arizona United States 85255
2 Scripps Health San Diego California United States 92121
3 Miami Dermatology & Laser Institute Miami Florida United States 33173
4 Meridian Clinical Research Savannah Georgia United States 31406
5 MediSearch Clinical Trials Saint Joseph Missouri United States 64506
6 Dermatology, Laser & Vein Institute Charlotte North Carolina United States 28207
7 Wake Research Associates Raleigh North Carolina United States 27612
8 International Clinical Research Murfreesboro Tennessee United States 37130
9 Austin Institute for Clinical Research Austin Texas United States 78660
10 The Center for Skin Research Katy Texas United States 77494
11 Premier Clinical Research Spokane Washington United States 99202

Sponsors and Collaborators

  • Sebacia, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sebacia, Inc.
ClinicalTrials.gov Identifier:
NCT03303170
Other Study ID Numbers:
  • SEB-0493
First Posted:
Oct 5, 2017
Last Update Posted:
Oct 14, 2019
Last Verified:
Oct 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Acne Vulgaris

Study Results

No Results Posted as of Oct 14, 2019