Clinical Trials Logo
  1. Home
  2. Acne Vulgaris
  3. NCT03303170
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT04321070 - Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris Phase 1
Recruiting NCT05755256 - The Impact of Probiotics on Skin Hydration in Youth With Mild Acne Phase 2
Completed NCT05131373 - Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris Phase 1
Completed NCT01445301 - Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects Phase 3
Completed NCT04698239 - Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions. N/A
Completed NCT02886715 - A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris Phase 3
Terminated NCT02924428 - Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris N/A
Not yet recruiting NCT02491060 - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris Phase 3
Not yet recruiting NCT02525822 - Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris Phase 2
Not yet recruiting NCT02535871 - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris Phase 3
Completed NCT02709902 - Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris Phase 1
Completed NCT02913001 - The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne N/A
Completed NCT02250430 - A Phase 1 Study Assessing Local Cutaneous Effects of SB204 Phase 1
Completed NCT01694810 - Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers Phase 1
Completed NCT01769664 - A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris Phase 1
Completed NCT01727440 - Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment N/A
Completed NCT01194375 - A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris Phase 2
Completed NCT01706250 - U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™ Phase 4
Completed NCT02524665 - 8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne Phase 4
Completed NCT00991198 - The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage Phase 2

External Links