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

Facial Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758041
• Other study ID #: SEB-0294CH, SEB-0400
• Status: Completed
• Phase: N/A
• First received: April 19, 2016
• Last updated: September 5, 2017
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: September 2017
• Source: Sebacia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris
• Facial Acne Vulgaris

Intervention

Device:
• Sebacia Microparticles

Locations

Country	Name	City	State
Denmark	Lasercenter North	Aalborg
Denmark	Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen	Copenhagen
Switzerland	SKINPULSE Dermatology Laser & Beauty Center	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Sebacia, Inc.

Countries where clinical trial is conducted

Denmark,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in lesion count from baseline		Baseline, Week 12, Week 24, Week 36
Secondary	Improvement in Investigator Global Acne Score		Baseline, Week 12, Week 24, Week 36