Evaluation of a Photopneumatic System for the Treatment of Acne

The purpose of the study is to evaluate the safety and efficacy of a photopneumatic therapy for the treatment of acne and concomitant symptoms associated with the disease, including erythema.

Study Overview

• Status: Completed
• Conditions: Mild to Moderate Acne
• Intervention / Treatment: Device: Photopneumatic therapy

Detailed Description

The primary aims of the study will be to demonstrate the safety and efficacy of using a photopneumatic system for treatment of mild to moderate acne on the face or body - including neck, chest, and back - of up to 24 subjects. To support this clinical assessment, the affected areas to be treated will be documented at baseline, at each subsequent treatment visit (up to 6 treatments), and at one (1) month and three (3) months following final treatment.

• Study Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

Study Locations

• United States
  • California
    • Hayward, California, United States, 94545
      • Solta Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All genders and ethnic backgrounds. No subjects from vulnerable categories (i.e. minors, pregnant women, etc).

Description

Inclusion Criteria:

1. Fitzpatrick skin type I-VI.
2. Male or female.
3. Subjects must be between 18 and 55 years of age.
4. Subjects must have mild to moderate acne (defined as 15 or more inflammatory or non-inflammatory lesions).
5. Subjects must read, understand, and sign the informed consent form.
6. Subjects must be willing and able to comply with all follow-up requirements.

Exclusion Criteria:

1. Subjects must not have active localized or systemic infections.
2. Subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid scar formation), atrophic dermatitis or immunologic abnormalities such as vitiligo.
3. Subjects must not have received microdermabrasion within one (1) month prior to enrollment.
4. Subjects must not have received immunosuppressive medication(s) one (1) month prior to enrollment.
5. Subjects must not have received laser or light treatment within the last three (3) months.
6. Subjects must not have received dermabrasion, TCA peel greater than 20%, botulinum toxin type A, dermal fillers, photodynamic therapy (PDT), or cosmetic surgery within the last six (6) months .
7. Subjects must not be currently taking or have used isotretinoin (e.g. Accutane) within six (6) months prior to enrollment.
8. Subjects must agree to refrain from using cosmeceutical agents or topical agents during the course of the study, except as directed by study investigators.
9. Subjects must not have had previous ablative laser treatment.
10. Subjects must refrain from excessive sun exposure during participation in this study.
11. Subjects must not have any condition that results in photosensitivity or be taking any medication containing aminolevulinic acid (E.g. Levulan).
12. Subjects must not be a current or past smoker of cigarettes and/or cigars.
13. Subjects must not be pregnant.
14. Any condition or situation that would prevent the subject from safely completing all protocol requirements for participation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Group	Device: Photopneumatic therapy; Use of intense pulsed light (photo) in combination with vacuum technology (pneumatic) to treat mild to moderate acne.

Collaborators and Investigators

• Sponsor: Solta Medical

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: December 8, 2010
• First Submitted That Met QC Criteria: December 8, 2010
• First Posted (Estimate): December 9, 2010

Study Record Updates

• Last Update Posted (Estimate): March 26, 2012
• Last Update Submitted That Met QC Criteria: March 22, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 10-116-CF-I