Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea

Inclusion Criteria:

- Subjects who had provided written informed consent to participate in the study.

- Male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of moderate to
severe facial rosacea, defined as the presence of: i. At least twelve and not more
than forty inflammatory facial lesions (i.e., papules/pustules), AND ii. Subjects with
a grade 3 or 4 on the 5-point Investigators Global Assessment (IGA) scale, AND iii.
Persistent facial erythema (scored as at least mild on Erythema Severity Scale), AND
iv. Facial telangiectasia (scored as at least mild on Telangiectasia Severity Scale.

- Subject willing to minimize external factors that might trigger rosacea flare-ups as
recommended per protocol and patient instructional guide (e.g., spicy foods, thermally
hot foods and drinks, hot environments, prolonged sun exposure, strong winds and
alcoholic beverages).

- Non-nursing, female subjects of child bearing potential, who are using an acceptable
form of birth control: total abstinence, oral (birth control pills), intravaginal:
(e.g. NuvaRing®), implantable (e.g. Norplant®), injectable (e.g. Depo-Provera®) or
transdermal (e.g. Ortho Evra®) contraception; intrauterine device (IUD);
double-barrier (diaphragm or condom with spermicidal gel or foam); for two months
prior to study enrollment or a vasectomized partner. All female subjects of child
bearing potential must have undergone an in-office urine pregnancy test, with a
negative result, prior to being randomized to receive study drug. In addition, women
of childbearing potential must have agreed to a have urine pregnancy test at Day 42
and at the end of the study (Day 84). Females not of childbearing potential due to
menopause must have been postmenopausal for at least one year. Male subjects must be
willing to not attempt to conceive a child during the participation in the study.
Females utilizing oral contraception must be willing to utilize an appropriate
secondary form of contraception during the study.

- Subjects who use the same brand of soap, make-up, hair products, or shaving
lotion/foam/cream/gel for a period of at least four weeks prior to the Baseline Visit
and agree not to change these product brand/types during the study, with the exception
of using the study approved cleanser and moisturizer with sunscreen provided by the
sponsor.

- Male subjects who are willing to shave, if applicable, at approximately the same time
every day.

- Subjects who are willing to refrain from sunbathing, using sun tanning booths/beds, or
excessive exposure to the sun for the duration of the study.

Exclusion Criteria:

- Presence of any skin condition on the face that would interfere with the diagnosis or
assessment of rosacea as determined by the Investigator.

- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere
with diagnosis or assessment of rosacea. Patients also must not grow excess facial
hair during the study (i.e. they need to be free of excess facial hair for follow-up
visits).

- History of hypersensitivity or allergy to minocycline, any other tetracycline or any
other component of the formulation, or known reactions to cleansers, including Ponds
Cold Cream, and moisturizer with sunscreen.

- Subjects using, or planning use of concomitant treatments within 30 days prior to
Baseline visit (e.g., facial or chemical peels, dermal fillers, acne surgery,
intralesional steroids, spironolactone, debridement, cryotherapy, dermabrasion, X-ray,
IPL, laser therapy or UV therapy).

- Use within 6 months prior to baseline of oral retinoids (e.g. isotretinoin, acitretin)
or therapeutic vitamin A supplements of greater than 10,000 International Units/day
(multivitamins are allowed).

- Subjects using estrogens or progestin agents (e.g., Gynogen, Valergen, Depo-Testadiol,
Depogen, birth control pills), for less than 2 months prior to the Baseline Visit.
(Subjects using estrogens for 2 months or more are not excluded unless the subject
expected to change dose, drug, or discontinue estrogen use during the study).

- Use within 2 month prior to the Baseline Visit of 1) topical retinoids to the face, 2)
systemic antibiotics known to have an impact on the severity of facial rosacea (e.g.,
containing tetracycline and its derivatives, erythromycin and its derivatives,
sulfamethoxazole, or trimethoprim, metronidazole), or 3) systemic corticosteroids.

- Use within 2 months prior to the Baseline Visit of 1) topical corticosteroids, 2)
topical antibiotics or 3) topical medications for rosacea (e.g., metronidazole,
azelaic acid, erythromycin, ivermectin, sulfur based topical products).

- Subjects with rhinophyma, dense telangiectasia, or plaque-like facial edema, more than
5 nodules or sinus tracts.

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

- Subjects with underlying diseases or other dermatological conditions, such as; atopic
dermatitis, perioral dermatitis, or seborrheic dermatitis, which required the use of
interfering topical or systemic therapy or may have interfered with the rosacea
diagnosis.

- Subjects using an investigational drug or participating in an investigational study
within 30 days of the Baseline Visit. Use of an investigational drug and/or
participation in another investigational study prohibited during this study.

- Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol
or drug abuse with in the past year.

- Medical history of immunodeficiency or other significant ongoing medical condition or
disease as determined by the investigator.