NCT02758041

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

April 19, 2016

Last Update Submit

September 5, 2017

Conditions

Facial Acne Vulgaris

Keywords

Acne

Outcome Measures

Primary Outcomes (1)

  • Percent reduction in lesion count from baseline

    Baseline, Week 12, Week 24, Week 36

Secondary Outcomes (1)

  • Improvement in Investigator Global Acne Score

    Baseline, Week 12, Week 24, Week 36

Study Arms (1)

Sebacia Microparticles

EXPERIMENTAL
Device: Sebacia Microparticles

Interventions

Sebacia MicroparticlesDEVICE
Sebacia Microparticles

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Lasercenter North

Aalborg, 9220, Denmark

Location

Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen

Copenhagen, 2400, Denmark

Location

SKINPULSE Dermatology Laser & Beauty Center

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Merete Haedersdal, MD, PhD

    Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2016

First Posted

May 2, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

September 7, 2017

Record last verified: 2017-09

Locations

DK(2)CH(1)