Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea

This is a 12-week, multicenter, double-blind, randomized, two-arm, vehicle controlled study.
Subjects will be randomized 1:1 to BPX-04 minocycline topical gel 1% or vehicle. This study
will include approximately 176 randomized subjects with inflammatory lesions of
papulopustular rosacea on the face, defined by an IGA score of 3 (moderate) or 4 (severe) at
Baseline. Subjects will be healthy male or female subjects aged 18 years or older. There will
be up to 20 study sites in the USA.

Subjects will apply approximately 1 gram of topical gel once each day for a 12 week duration.
They will come to the study site at Screening, Baseline, and Weeks 4, 8, and 12 or early
termination (ET) for the protocol required efficacy and safety evaluations.

At each visit, efficacy will be assessed by rosacea lesion counts, IGA, PGI-S, PGI-I, CGI-S,
CGI-I, RosaQoL, Erythema Assessment Scale, Telangiectasia Assessment Scale and subject
satisfaction questionnaire.

Safety will be assessed with vital signs, physical examination, laboratory tests such as
clinical hematology and chemistries, investigators' and subjects' assessments of cutaneous
tolerability, incidence of minocycline-induced skin hyperpigmentation, incidence of visual
disturbances and/or headaches suggestive of pseudotumor cerebri, and incidence of TEAEs.
Blood samples will be collected to evaluate the level of minocycline in plasma at Baseline
and Week 12/ET.

Inclusion Criteria:

1. Male or female subjects ≥18 years of age at the time of consent.

2. Subjects do not have any medical conditions, other than rosacea, that in the opinion
of the investigator, put the subject at unacceptable risk or could interfere with
study assessments or integrity of the data.

3. A clinical diagnosis of moderate to severe (Grade 3 or 4) facial rosacea
(papulopustular (Subtype 2) or mixed erythematotelangiectatic (Subtype 1) and
papulopustular (Subtype 2)) as determined by the Investigator's Global Assessment
(IGA)

4. Have 15-70 papulopustular lesions of rosacea on the face with no more than 2 nodules.

5. Female subjects of childbearing potential are willing to use effective contraceptive
method (s) for at least 4 weeks before Baseline and at least 4 weeks after the last
study product administration or have a sterilized or same sex partner for the duration
of the study. Effective contraceptive methods are: systemic hormonal contraceptives,
intrauterine device or barrier method of contraception in conjunction with spermicide
or agree to sexual abstinence. Hormonal contraceptives must be on a stable dose for at
least 12 weeks before Baseline. Subjects using low dose (≤35 ug ethinyl estradiol)
oral contraceptives must use a second form of birth control (e.g., barrier method such
as condoms with spermicide).

6. Female subjects of childbearing potential must have a negative urine pregnancy test
(dipstick).

7. Subjects who use make-up, facial moisturizers, creams, lotions, cleansers and/or
sunscreens must have used the same product brands/types for a minimum period of 2
weeks prior to Baseline, must agree not to change brand/type or frequency of use
throughout the study and must agree not to use make-up, facial moisturizers, creams,
lotions, cleansers and/or sunscreens on the scheduled clinic visit days before the
visit.

8. Be willing to limit or avoid known personal 'triggers' of rosacea such as spicy foods,
consumption of alcoholic beverages, extended sun exposure, tanning beds, etc., for the
duration of the study.

9. Subjects must be capable of giving informed consent and the written informed consent
must be obtained prior to any study-related procedures.

Exclusion Criteria:

1. Have a history of skin disease, presence of skin condition, scarring or excessive
facial hair the PI believes would interfere with the study.

2. Have moderate or severe rhinophyma, severe telangiectasia or plaque-like facial edema.

3. Have rosacea conglobata or fulminans, corticosteroid induced rosacea or facial
erythrosis other than rosacea.

4. Have ocular rosacea of a severity that requires systemic treatment.

5. Have a history of any adverse reaction to minocycline or other tetracycline class
antibiotic.

6. Have a clinically significant chemistry or hematology value or have an ALT or AST that
is greater than or equal to 2x normal.

7. Have any conditions or factors that the PI believes may affect the response of the
skin or the interpretation of the results.

8. Have a history of symptoms that might be confused with a diagnosis of pseudotumor
cerebri such as severe headaches or visual disturbances inconsistent with a diagnosis
of migraine or have a history of traumatic brain injury with headache and/or visual
disturbances.

9. Have used on the face an over the counter (OTC) topical medication for the treatment
of rosacea within 4 weeks prior to Baseline.

10. Have used prescription topical (on the face) and/or oral antibiotics within 4 weeks
prior to Baseline.

11. Treatment with hormonal therapy or oral corticosteroids that is not on a stable dose
and frequency for at least 12 weeks before Baseline and not stable throughout the
study.

12. Have had a facial procedure such as chemical peel, laser, microdermabrasion or
injections with a dermal filler or neuromodulator within 8 weeks prior to Baseline.

13. Have received photodynamic therapy or phototherapy to the face within 12 weeks prior
to Baseline.

14. Have used an oral retinoid within 6 months or a topical retinoid within 3 months prior
to Baseline.

15. Current drug or alcohol abuse.

16. Female subject who is breastfeeding, pregnant or who is planning a pregnancy during
the study.

17. Participated in any clinical study with exposure to any investigational treatment or
product within the previous 4 weeks to Baseline, or plan on concurrent participation
in other studies.