Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris

Multi-center, prospective, open-label study utilizing before-after study design. Up to 20
healthy subjects, age 18 - 55 years with acne vulgaris who wish to improve their skin
appearance will be randomized to receive either Diamondpolar applicator (radio frequency and
pulsed magnetic field) treatment followed by AC Dual applicator (intense pulsed light)
treatment or AC Dual applicator (intense pulsed light) treatment alone using the Venus Versa
system. Duration of subject participation will be approximately 10 weeks (4 weekly treatments
with a follow-up visit scheduled 6 weeks after the last treatment).

The AC Dual applicator (IPL) is indicated for the treatment of acne vulgaris by using a blue
light (415 nm) to target porphyrins produced by the P. acne bacteria, destroying the bacteria
and uses the red light (630 nm) to help reduce inflammation, inhibit sebum production and
improve healing.

The addition of the Diamondpolar applicator (RF and PEMF) treatment is thought to target the
sebaceous gland, causing it to shrink and decrease sebum output

Inclusion Criteria:

- Fitzpatrick skin phototype I - VI

- Having mild to moderate acne vulgaris (as defined by the Acne Global Severity Scale)
and have at least 10 inflammatory and 15 non-inflammatory lesions, but no
nodulo-cystic lesions.

- Subject who can commit to all treatments and follow up.

Exclusion Criteria:

- Superficial metal or other implants in the treatment area.

- Current or history of cancer, or current condition of any type of cancer, or
pre-malignant moles.

- Pregnancy and nursing.

- Patients with cystic acne, acne conglobata, acne fulminans, or secondary acne
(chloracne, drug-induced acne, etc)

- Diseases which may be stimulated by light at the wavelengths used, such as history of
Systemic Lupus Erythematosus, Porphyria, and Epilepsy.

- Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex
in the treatment area, may be treated only following a prophylactic regimen.

- Poorly controlled endocrine disorders, such as Diabetes or Polycystic Ovary Syndrome.

- Any active condition in the treatment area, such as sores, Psoriasis, eczema, and
rash.

- Tattoos, scars or piercings in the treated area.

- History of skin disorders, keloids, abnormal wound healing, as well as very dry and
fragile skin.

• Use of medications, herbs, food supplements, and vitamins known to induce
photosensitivity to light exposure at the wavelengths used, such as Isotretinoin
(Accutane) within the last six months, tetracyclines, or St. John's Wort within the
last two weeks.

- Any surgical procedure in the treatment area within the last three months or before
complete healing.

- Treating over tattoo or permanent makeup.

- Excessively tanned skin from sun, tanning beds or tanning creams within the last two
weeks.

- As per the practitioner's discretion, refrain from treating any condition which might
make it unsafe for the patient.

- Exposure to investigational product within 3 months (or designated half-life) prior to
enrollment.

- Prior drugs, interventions, skin laser/light or another device for Acne treatment
within 3 months of initial treatment or during the course of the study.