A Trial of Pulse Dyed Laser (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris

Inclusion Criteria:

- Subjects who are able to give voluntary, written informed consent to participate in
this study and from whom consent has been obtained including HIPAA authorization.

- Healthy male or non-pregnant female 18-65 years-of-age with a clinical diagnosis of
mild to moderate facial acne vulgaris.

- Subject must have at least eight and not more than fifty inflammatory facial lesions
(i.e., papules/pustules) and no nodules on the face. For the purposes of study
treatment and evaluation, these lesions should be limited to the facial treatment
area including those present on the nose. Lesions involving the eyes, and scalp
should be excluded from the count.

- Subject must be in general good health and free from any clinically significant
disease, other than acne, that might interfere with the study evaluations.

- Female subjects of childbearing potential (excluding women who are surgically
sterilized or postmenopausal for at least 1 year), in addition to having a negative
urine pregnancy test, must be willing to use an acceptable form of birth control
during the study from the day of the first dose administration to 30 days after the
last administration of study drug.

- Subjects who use make-up must have used the same brands/types of make-up for a
minimum period of 14 days prior to study entry and must agree to use the same make-up
brand/type and frequency of use throughout the study.

- Subjects must agree not to have any other procedures affecting skin quality
(microdermabrasion, peels, acne treatments, etc.) for the duration of the study.

- Subjects must understand the study and be able to follow study instructions as well
as attend the required study visits.

- Subjects who agree to be photographed for research purposes and their identity may
not be concealed in these photographs.

Exclusion Criteria:

- Subjects whom are pregnant, planning to become pregnant or breastfeeding. A urine
pregnancy test will be done to rule out pregnancy.

- Subjects of child-bearing potential who are not using an approved method of birth
control (oral contraceptives, IUD, contraceptive implant, barrier methods with
spermicide or abstinence). Females of non-childbearing potential are defined as
post-menopausal (absence of menstrual bleeding for one year), hysterectomy or
bilateral oophorectomy.

- Subjects who cannot understand or are not willing to comply with the requirements of
the study.

- Presence of any skin condition on the face that would interfere with the diagnosis or
assessment of acne.

- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere
with diagnosis or assessment of acne.

- The use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or
therapeutic vitamin A supplements of greater than 10,000units/day (multivitamins are
allowed).

- The use of estrogens or oral contraceptives for less than 3 months prior to baseline.

- The use within 1 month prior to baseline of:

- topical retinoids to the face;

- systemic antibiotics known to have an impact on the severity of facial acne
(e.g., containing tetracycline and its derivatives, erythromycin and its
derivatives, sulfamethoxazole, or trimethoprim);

- systemic corticosteroids (Note: intranasal and inhalational corticosteroids do
not require a washout and maybe used throughout the trial if the subject is on a
stable dose).

- Use within 2 weeks prior to baseline of:

- topical corticosteroids;

- topical antibiotics;

- topical medications for acne (e.g., metronidazole).

- Subjects with moderate or severe rhinophyma, dense telangiectases (score 3, severe),
or plaque-like facial edema.

- Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient
severity to require topical or systemic antibiotics.

- A subject who has used a sauna during the 2 weeks prior to study entry and during the
study.

- Subjects who have performed wax epilation of the face within 14 days prior to
baseline.

- A subject with bacterial folliculitis.

- A subject who consumes excessive alcohol, abuses drugs or has a condition that could
compromise the subject's ability to comply with study requirements.

- Subjects who engage in activities that involve excessive or prolonged exposure to
sunlight or weather extremes, such as wind or cold.

- A subject who has any clinically significant condition or situation, other than the
condition being studied that, in the opinion of the Investigator, would interfere
with the study evaluations or optimal participation in the study.

- A subject who has used any topical azelaic acid therapy within 30 days of baseline
visit.

- Subjects who have participated in an investigational drug study (i.e., subjects have
been treated with an Investigational Drug) within 30 days prior to baseline will be
excluded from study participation. Subjects who are participating in non-treatment
studies such as observational studies or registry studies can be considered for
inclusion.

- Subjects who have been previously enrolled in this study.

- Subjects who have had laser therapy (for telangiectasia or other conditions),
electrodessication and phototherapy to the facial area within 180 days prior to study
entry.

- Subjects who have had cosmetic procedures (e.g., facials) which may affect the
efficacy and safety profile of the Investigational Product within 14 days prior to
study entry.

- Subjects who have had any kind of facial dermabrasion, chemical peel, laser, IPL or
any other treatment that could influence the skin quality in the past 6 months or for
the duration of the study

- Subjects who do not agree to avoid using tanning beds or intensive exposure to the
sun two weeks prior to each office visit.

- Subjects who have any known cancer including skin cancers (basal cell carcinoma,
squamous cell carcinoma and melanoma) in the treatment area.

- Subjects who are currently involved in any injury litigation claims.