| Eligibility |
Inclusion Criteria:
1. Male or non-pregnant, non-lactating female aged = 18 and = 65 years.
2. Subjects must have understood, and signed IRB/IEC approved written ICF.
3. Subjects must be willing to refrain from using all other antibiotics during the
16-week treatment period, other than the IP.
4. Women of childbearing potential* must not be pregnant or lactating at the time of
screening visit as documented by a negative urine pregnancy test.
5. Women of childbearing potential must be willing to use an acceptable form of birth
control during the trial from the day of the first dose administration to 30 days
after the last administration of trial drug.
6. All male subjects must agree to use accepted methods of birth control with their
partners, throughout the study and until 30 days after the last administration of
trial drug.
7. Subjects must be in good health and free from any clinically significant disease,
which may interfere with the evaluation of microbiota or the administration of the IP.
Exclusion Criteria:
1. Female subjects who are pregnant, lactating or planning to become pregnant during
trial participation.
2. History of allergy or known sensitivity to minocycline, doxycycline, other
tetracycline, or any component of the study medication.
3. Clinically significant abnormal laboratory test results that, in the opinion of the
Investigator, would compromise the subject's safety or ability to participate in the
trial
4. History of organ transplant requiring immunosuppression, HIV, or other immune
compromised state.
5. History of lupus-like syndrome, autoimmune hepatitis, vasculitis, or serum sickness.
6. Any clinically significant condition that, in the opinion of the Investigator, would
interfere with the study evaluations or would place the trial subject at undue safety
risk.
7. Subjects with an active acute or chronic systemic infections
8. Subjects with planned surgery during the trial or within 30 days after the last dose
administration
9. Subjects who cannot avoid excessive exposure to UV radiation (use of tanning booths or
extended /occupational exposure to sunlight)
10. Subjects that have a medical history of photosensitivity or hyperpigmentation
11. Female subjects with medical history within 3 months prior to randomization of having
vaginitis or that use a vaginal douche or vaginal cleaning agent within 48 hours of
any visit
12. Subjects who used the following
1. Non-tetracycline antibiotics (systemic) within 6 weeks prior to Baseline (BL)
2. Tetracycline antibiotics (systemic) within 3 months prior to BL
13. Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or
use drugs of abuse (including, but not limited to, cannabinoids, cocaine and
barbiturates) within one year prior to screening
14. Subjects who have been treated with systemic retinoids or therapeutic Vitamin A
supplements > 10,000 IU/ day (multivitamin tablets are allowed) within 180 days prior
to the BL
15. Subjects who are on anti-coagulants or those likely to require anti-coagulants during
the trial period
16. Subjects who have used methoxyflurane or other nephrotoxic drugs (in the opinion of
the Investigator) within the past 30 days of BL
17. Subjects who have used topical retinoids or topical antibiotics to the face 30 days
prior to BL
18. Subjects who have used on their facial skin within 30 days prior to BL topical
corticosteroids, topical anti-mycotic, topical azelaic acid or ivermectin
19. Subjects who have participated in an investigational drug trial (i.e., subjects have
been treated with an investigational drug) within 30 days prior to BL or where
sufficient washout period has not been achieved; whichever period is longer.
20. Subjects having symptoms of COVID-19 or have had close contact with someone with
suspected or confirmed SARS-CoV-2 infection within 10 days prior to screening or who
are at high risk of SARS-CoV-2 infection.
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