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Trial record 69 of 289 for:    acne AND moderate

Evaluation of a Photopneumatic System for the Treatment of Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01257555
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : March 26, 2012
Information provided by (Responsible Party):
Valeant Pharmaceuticals ( Solta Medical )

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.

Condition or disease Intervention/treatment
Mild to Moderate Acne 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.

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : December 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All genders and ethnic backgrounds. No subjects from vulnerable categories (i.e. minors, pregnant women, etc).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01257555

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United States, California
Solta Medical
Hayward, California, United States, 94545
Sponsors and Collaborators
Solta Medical

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Responsible Party: Solta Medical Identifier: NCT01257555     History of Changes
Other Study ID Numbers: 10-116-CF-I
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: March 2012