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Evaluation of a Photopneumatic System for the Treatment of Acne

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Solta Medical
ClinicalTrials.gov Identifier:
NCT01257555
First received: December 8, 2010
Last updated: March 22, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Mild to Moderate Acne
 Device: Photopneumatic therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by Solta Medical:

Estimated Enrollment: 24
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment Group Device: Photopneumatic therapy
Use of intense pulsed light (photo) in combination with vacuum technology (pneumatic) to treat mild to moderate acne.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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).

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257555

Locations
United States, California
Solta Medical
Hayward, California, United States, 94545
Sponsors and Collaborators
Solta Medical
  More Information

No publications provided

Responsible Party: Solta Medical
ClinicalTrials.gov Identifier: NCT01257555     History of Changes
Other Study ID Numbers: 10-116-CF-I
Study First Received: December 8, 2010
Last Updated: March 22, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on May 21, 2013