Safety Study of Plasma Treatment System to Treat Back Acne

NCT01662349 | Terminated

• 1 other identifier: MOE - 121
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Change in number of reported adverse events

  Change from Baseline to 1 month post-treatment

Study Arms (1)

Plasma

EXPERIMENTAL

Plasma applied to back for up to 20 minutes, twice/week for 4 weeks

Device: MOE Antimicrobial Plasma Treatment System

Interventions

MOE Antimicrobial Plasma Treatment System DEVICE

Plasma applied to back for up to 20 minutes, twice/week for 4 weeks

Plasma

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Any nodulo-cystic lesions at Baseline
• Pregnancy or breast feeding
• Use of acne devices or systemic therapy with antibiotics within four months prior to start and throughout the duration of the study
• Intake of any oral retinoids within four months prior to study start and throughout the duration of the study
• Topical use of topical retinoids within two weeks prior to study start and throughout the duration of the study
• 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
• Use of an experimental drug or device within 30 days prior to study start;
• Intake of hormonal therapy within 3 months prior to study start
• 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.
• 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.
• 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.
• History or evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication
• Any significant medical conditions that could confound the interpretation of the study results.
• History of/or current skin cancer cancer
• Use of tanning booths, sun lamps within the past 2 weeks or during the study

Sponsors & Collaborators

• Moe Medical Devices: lead

Study Sites (1)

Clinical Unit for Research Trials and Outcomes in Skin (CURTIS)

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Alexandra B. Kimball, MD

  Partners Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 10, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

US (1)