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Status unknownNCT03818555Updated Oct 27, 2020

Sebacia Postmarket Study of Real-World Use

An interventional study of Sebacia Microparticles Treatment in Acne Vulgaris, sponsored by Sebacia, Inc.. Status unknown at 6 sites in United States. Open to participants aged 12 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-10-27.

Sponsored by Sebacia, Inc. · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
125
Allocation
Not applicable
Ages
12 Years to 45 Years
Sex
All
01

Study summary

Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.

02

Conditions studied

  • Acne Vulgaris

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03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's planned enrollment of 125 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Sebacia, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Mild to moderate facial inflammatory acne vulgaris (IGA 2 or 3)
  • Between 10 and 50 papules/pustules
  • Fitzpatrick skin phototype I, II or III
  • Able to provide informed consent and comply with study schedule and other requirements

Exclusion criteria

Exclusion Criteria:

  • Moderately severe or severe acne vulgaris (IGA 4 or 5)
  • Nodulocystic acne, significant scarring or excoriation
  • Requires oral retinoid, antibiotic or corticosteroid for acne
  • New or fluctuating hormone or hormone-regulating therapy
  • Photosensitivity or allergy to gold
  • Medical or mental health condition that would pose a risk to patient or impair treatment and evaluation
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
125 participants (estimated)

Study arms

  • Other
    Sebacia Microparticles Treatment

    Other: Sebacia Microparticles Treatment

Interventions

  • OtherSebacia Microparticles Treatment

    Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.

    Also known as: Sebacia treatment, Microparticles and Nd:Yag laser treatment

06

What researchers measure

Primary outcomes

  1. Inflammatory Lesion Count

    Percent change in number of inflammatory lesions from baseline

    Time frame: Months 2, 3, 6, 9 and 12

Secondary outcomes

  1. Investigator's Global Assessment

    Percent of subjects clear (IGA 0) or almost clear (IGA 1)

    Time frame: Months 2, 3, 6, 9 and 12

  2. Physician's Overall Assessment of Improvement

    Categorical improvement from baseline (worse, no change, minimal, moderate, marked, complete)

    Time frame: Months 2, 3, 6, 9 and 12

07

Study locations

6 sites
  • Miami Dermatology & Laser Institute
    Miami, Florida 33173, United States
  • Dermatology Institute of Boston
    Boston, Massachusetts 02116, United States
  • International Clinical Research
    Murfreesboro, Tennessee 37130, United States
  • Austin Institute for Clinical Research - Central
    Austin, Texas 78705, United States
  • Austin Institute for Clinical Research - Pflugerville
    Pflugerville, Texas 78660, United States
  • Premier Clinical Research
    Spokane, Washington 99202, United States
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03818555
Lead sponsor
Sebacia, Inc.
Responsible party
Sponsor
First posted
Jan 28, 2019
Start date
Jan 1, 2019
Primary completion
Jun 2021 (estimated)
Completion
Jun 2021 (estimated)
Last update
Oct 27, 2020

Study contacts

VP, Clinical & Regulatory Affairs
study director · Sebacia, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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