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Safety Study of Plasma Treatment System to Treat Back Acne

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Moe Medical Devices.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Moe Medical Devices
ClinicalTrials.gov Identifier:
NCT01662349
First received: August 2, 2012
Last updated: September 11, 2012
Last verified: September 2012

August 2, 2012
September 11, 2012
August 2012
June 2013   (final data collection date for primary outcome measure)
Change in number of reported adverse events [ Time Frame: Change from Baseline to 1 month post-treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01662349 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of Plasma Treatment System to Treat Back Acne
A Single Center, Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Plasma Treatment System in Treating Back Acne

The purpose of this study is to evaluate the safety of treating human skin with atmospheric plasma and get an initial evaluation of the efficacy of this treatment for acne.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acne Vulgaris
Device: MOE Antimicrobial Plasma Treatment System
Plasma applied to back for up to 20 minutes, twice/week for 4 weeks
Experimental: Plasma
Plasma applied to back for up to 20 minutes, twice/week for 4 weeks
Intervention: Device: MOE Antimicrobial Plasma Treatment System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
Not Provided
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males and non-pregnant, non-nursing females age 18-40 years old.
  2. Presence of clinically-evident back acne.
  3. Minimum of 20 non-inflammatory lesions (open and closed comedones)
  4. Minimum of 30 total lesions (sum of inflammatory and non-inflammatory)
  5. Subject must have measurable sebum production.
  6. Subjects must be in generally good health.
  7. Must be able and willing to comply with the requirements of the protocol.

Exclusion Criteria:

  1. Any nodulo-cystic lesions at Baseline
  2. Pregnancy or breast feeding
  3. Use of acne devices or systemic therapy with antibiotics within four months prior to start and throughout the duration of the study
  4. Intake of any oral retinoids within four months prior to study start and throughout the duration of the study
  5. Topical use of topical retinoids within two weeks prior to study start and throughout the duration of the study
  6. Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study
  7. Use of an experimental drug or device within 30 days prior to study start;
  8. Intake of hormonal therapy within 3 months prior to study start
  9. Use of topical products on the back containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
  10. Concomitant use of mega-doses of certain vitamins, such as vitamin D (>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
  11. Procedures on the skin of the back such as chemical or laser peel, microdermabrasion, photodynamic therapy) within the past 2 weeks or during the study.
  12. History or evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication
  13. Any significant medical conditions that could confound the interpretation of the study results.
  14. History of/or current skin cancer cancer
  15. Use of tanning booths, sun lamps within the past 2 weeks or during the study
  16. Any metallic implants or prostheses in the vicinity of the treatment site (such as shoulders, back, spine, pacemakers, etc.).
  17. Any known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
  18. History of significant post-inflammatory hyperpigmentation at the sites of acne lesions.
  19. History of or is currently immunocompromised.
Both
18 Years to 40 Years
No
Contact: Alexandra B. Kimball, MD 617-726-5066 harvardskinstudies@partners.org
United States
 
NCT01662349
MOE - 121
Not Provided
Moe Medical Devices
Moe Medical Devices
Not Provided
Principal Investigator: Alexandra B. Kimball, MD Partners Healthcare System
Moe Medical Devices
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP