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Completed

NCT Number: NCT02758041

A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris

This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory acne vulgaris.

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Key information

Conditions

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

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lasercenter North, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, 16-45 years of age.
  • Moderate to moderately-severe facial inflammatory acne vulgaris
  • Fitzpatrick skin phototype I-III

Exclusion criteria

  • Pregnant, lactating, nursing or planning to become pregnant
  • Tattoo in the treatment area
  • Active skin disease, excessive scarring or excess facial hair in the treatment area
  • Certain current or recent acne treatments
  • Recent light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area
  • Contraindicated for laser treatment, or is unable or unwilling to avoid excessive sun exposure or tanning bed use
  • Known allergy to gold

Treatment and study plan

Sebacia Microparticles

Device

Primary outcomes

  1. Percent reduction in lesion count from baseline

    Time frame: Baseline, Week 12, Week 24, Week 36

Secondary outcomes

  1. Improvement in Investigator Global Acne Score

    Time frame: Baseline, Week 12, Week 24, Week 36

Sponsors and collaborators

Lead sponsor

Sebacia, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 2, 2016
Registry last updated
Sep 7, 2017

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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