Safety Study of Plasma Treatment System to Treat Back Acne

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.