Safety Study of Plasma Treatment System to Treat Back Acne

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Moe Medical Devices
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
  Purpose

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.


Condition Intervention
Acne Vulgaris
Device: MOE Antimicrobial Plasma Treatment System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Center, Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Plasma Treatment System in Treating Back Acne

Resource links provided by NLM:


Further study details as provided by Moe Medical Devices:

Primary Outcome Measures:
  • Change in number of reported adverse events [ Time Frame: Change from Baseline to 1 month post-treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: August 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plasma
Plasma applied to back for up to 20 minutes, twice/week for 4 weeks
Device: MOE Antimicrobial Plasma Treatment System
Plasma applied to back for up to 20 minutes, twice/week for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662349

Contacts
Contact: Alexandra B. Kimball, MD 617-726-5066 harvardskinstudies@partners.org

Locations
United States, Massachusetts
Clinical Unit for Research Trials and Outcomes in Skin (CURTIS) Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Alexandra B. Kimball, MD         
Sponsors and Collaborators
Moe Medical Devices
Investigators
Principal Investigator: Alexandra B. Kimball, MD Partners Healthcare System
  More Information

No publications provided

Responsible Party: Moe Medical Devices
ClinicalTrials.gov Identifier: NCT01662349     History of Changes
Other Study ID Numbers: MOE - 121
Study First Received: August 2, 2012
Last Updated: September 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014