Evaluation of a Photopneumatic System for the Treatment of Acne

Completed

Conditions studied: Mild to Moderate Acne

In brief

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.

Key facts

Study ID

NCT01257555

Run by

Solta Medical

People needed

24

Starts

2010-12-01

Expected to finish

2011-09-01

Last updated by the study team

2012-03-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Subjects must not have active localized or systemic infections.
• 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.
• Subjects must not have received microdermabrasion within one (1) month prior to enrollment.
• Subjects must not have received immunosuppressive medication(s) one (1) month prior to enrollment.
• Subjects must not have received laser or light treatment within the last three (3) months.
• 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 .
• Subjects must not be currently taking or have used isotretinoin (e.g. Accutane) within six (6) months prior to enrollment.
• Subjects must agree to refrain from using cosmeceutical agents or topical agents during the course of the study, except as directed by study investigators.
• Subjects must not have had previous ablative laser treatment.
• Subjects must refrain from excessive sun exposure during participation in this study.
• Subjects must not have any condition that results in photosensitivity or be taking any medication containing aminolevulinic acid (E.g. Levulan).
• Subjects must not be a current or past smoker of cigarettes and/or cigars.
• Subjects must not be pregnant.
• Any condition or situation that would prevent the subject from safely completing all protocol requirements for participation.

Where it is running

• Solta Medical — Hayward, California, United States

Full record on ClinicalTrials.gov

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