Evaluation of a Photopneumatic System for the Treatment of Acne

NCT01257555 | Completed DMC

• 1 other identifier: 10-116-CF-I
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild to Moderate Acne

Study Arms (1)

Treatment Group

Device: Photopneumatic therapy

Interventions

Photopneumatic therapy DEVICE

Use of intense pulsed light (photo) in combination with vacuum technology (pneumatic) to treat mild to moderate acne.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• Solta Medical: lead

Study Sites (1)

Solta Medical

Hayward, California, 94545, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: December 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

US (1)