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Completed

NCT Number: NCT03303170

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

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

Completed

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clear Dermatology & Aesthetics Center, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sebacia Microparticles

Device

Topical microparticle suspension

Nd:Yag Laser

Device

Laser delivering 1064 nm wavelength light

Primary outcomes

  1. Change in number of inflammatory acne lesions

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

Sebacia, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2017
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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