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

NCT ID: NCT02758041

Last Updated: 2017-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-02-28

Brief Summary

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

Detailed Description

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Conditions

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Facial Acne Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sebacia Microparticles

Group Type EXPERIMENTAL

Sebacia Microparticles

Intervention Type DEVICE

Interventions

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Sebacia Microparticles

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sebacia, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Merete Haedersdal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen

Locations

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Lasercenter North

Aalborg, , Denmark

Site Status

Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen

Copenhagen, , Denmark

Site Status

SKINPULSE Dermatology Laser & Beauty Center

Geneva, , Switzerland

Site Status

Countries

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Denmark Switzerland

Other Identifiers

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SEB-0294CH, SEB-0400

Identifier Type: -

Identifier Source: org_study_id

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