| Eligibility |
Inclusion Criteria:
For Cohorts 1-5:
- Male or female participants aged 18 to 45 years, inclusive, at the time of consent
- Participant has moderate to severe non-nodular facial acne vulgaris.
- Participant's treatment with hormonal therapy (including, but not limited to, topical
application, oral administration, implant, intrauterine device [IUD]) has been on a
stable dose and frequency for at least 12 weeks before Day 1, and participant agrees
to maintain current dose and frequency throughout the study.
- Female participants of childbearing potential and male participants and their female
partners who are of childbearing potential must agree to use a highly effective
contraceptive method
- Participant is willing to participate and is capable of giving informed consent. Note:
Consent must be obtained prior to any study-related procedures.
Additional Inclusion Criteria for Cohort 4 only:
• Participant has additional acne lesions on the upper back with at least 5 inflammatory
lesions and additional acne lesions on the posterior neck, shoulders, and/or upper chest.
Exclusion Criteria:
For Cohorts 1-5:
- Participant is a female who is breastfeeding, pregnant, or who is planning to become
pregnant during the study.
- Participant has acne fulminans, conglobata, nodulocystic acne, or secondary acne.
- Participant has a history of skin disease or presence of skin condition that, in the
opinion of the investigator, would interfere with the study assessments.
- Excessive facial hair that would interfere with diagnosis or assessment of acne
vulgaris
- Participant is known to have immune deficiency or is immunocompromised.
- Participant has a history of cancer or lymphoproliferative disease within 5 years
prior to Day 1. Participants with successfully treated nonmetastatic cutaneous
squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
may be candidates for the study.
- Participant had a major surgery within 8 weeks prior to Day 1 or has a major surgery
planned during the study.
- Participant has positive results for hepatitis B surface antigens (HBsAg), antibodies
to hepatitis B core antigens (anti-HBc), hepatitis C virus (HCV), or human
immunodeficiency virus (HIV).
- Participant has used on the treated areas an over-the-counter (OTC) topical medication
for the treatment of acne vulgaris, including benzoyl peroxide, topical
anti-inflammatory medications, corticosteroids, salicylic acid, a-hydroxy/glycolic, or
antibacterial/antiseptic soap or wash within 2 weeks prior to Day 1.
- Participant has used prescription topical retinoid (e.g., tretinoin, tazarotene,
adapalene), dapsone or antimicrobials (e.g., clindamycin, erythromycin), or other
prescription topical medications for the treatment of acne vulgaris within 4 weeks
prior to Day 1. Topical antibiotics may be used to treat non-acne skin lesions outside
of the treated area.
- Participant has used systemic antibiotics or other systemic anti-acne drugs not
mentioned in other exclusion criteria within 4 weeks prior to Day 1.
- Participant has used oral or injectable corticosteroids within 4 weeks prior to Day 1
or require them during the study. Note: Intranasal corticosteroids and inhaled
corticosteroids are allowed. Eye and ear drops containing corticosteroids are also
allowed.
- Participant had a facial procedure (including, but not limited to, chemical peel,
laser, microdermabrasion) within 8 weeks prior to Day 1 and during the study.
- Participant has received photodynamic therapy or phototherapy within 12 weeks of Day
1.
- Participant has used androgen receptor blockers (such as spironolactone or flutamide)
within 12 weeks prior to Day 1.
- Participant has used drospirenone, chlormadinone acetate, or cyproterone acetate
within 26 weeks prior to Day 1.
- Participant has used oral retinoid (e.g., isotretinoin) within 52 weeks prior to Day 1
or vitamin A supplements >10,000 Units per day (U/d) within 26 weeks prior to Day 1.
- Participant is currently receiving a nonbiological investigational product or device
or has received one within 4 weeks or five half-lives (whichever is longer) prior to
Day 1.
- Participant has received blue light, laser, intense pulsed light or other light
therapy on the face within 4 weeks prior to Day 1.
- Participants who have given > 50 milliliters (mL) of blood or plasma within 30 days of
Screening or > 499 mL of blood or plasma within 56 days of Screening (during a
clinical trial or at a blood bank donation).
- Participant has a known history of clinically significant drug or alcohol abuse in the
last year prior to Day 1, or has a positive drug screen and/or positive alcohol test
result at the Screening visit or at Day 1 (excluding cannabinoids).
- Participant has had excessive sun exposure or has used tanning booths within 4 weeks
prior to Day 1 or is not willing to minimize natural and artificial sunlight exposure
during the study. Use of sunscreen products (except on treated areas) and protective
apparel are recommended when sun exposure cannot be avoided.
For Cohorts 1-3 only:
• Participant has a Fitzpatrick's Skin Phototype =5.
For Cohort 4 only, due to biopsy collection:
- Participant has a history of an allergic reaction or significant sensitivity to
lidocaine or other local anesthetics.
- Participant has a history of hypertrophic scarring or keloid.
- Participant has taken anticoagulant medication, such as heparin, low molecular weight
(LMW)-heparin, warfarin, antiplatelets, within 2 weeks prior to Day 1, or has a
contraindication to skin biopsies. Nonsteroidal anti-inflammatory drugs (NSAIDs) will
not be considered antiplatelets and will be allowed.
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