Moderate to Severe Acne Vulgaris
Conditions
Keywords
BOS-356, acne
Brief summary
This study is being conducted to characterize the safety and tolerability of BOS-356 in adult participants with moderate to severe acne vulgaris following 14 days or 28 days of repeated topical application
Detailed description
In Cohorts 1-3, participants will be randomized to receive twice daily (BID) topical applications of BOS-356 gel or vehicle gel to the face during a 14-day treatment period. Doses will be escalated in successive cohorts with BOS-356 gel 0.1%, 0.4%, and 0.7%. In Cohort 4, participants will be randomized to receive BID topical applications of BOS-356 gel or vehicle gel to the face, upper chest, upper back, shoulders, and posterior neck during a 28-day treatment period. The dose of BOS-356 to be used in this cohort will be determined based on safety and tolerability data from Cohorts 1-3. In Cohort 5, participants will complete a 7-day run-in period to receive BID topical applications of vehicle gel to the face. Participants will be randomized to receive BID topical applications of BOS-356 gel or vehicle gel to the face during a 28-day treatment period. The dose of BOS-356 to be used in this cohort will be the same as the dose used in Cohort 4. Cohorts 4 and 5 may proceed in parallel.
Interventions
DRUGBOS-356
topical gel
DRUGVehicle
topical gel
Sponsors
Boston Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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, α-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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohorts 4 and 5: Number of participants with any clinically significant change from baseline in ECG findings | up to Day 35 for each cohort |
| Cohort 5: Number of participants with a mild, moderate, and severe score in LTAs | up to Day 42 |
| Cohorts 4 and 5: Number of participants with any clinically significant change from baseline in clinical laboratory parameter values | up to Day 35 for each cohort |
| Cohorts 4 and 5: Number of participants with any clinically significant change from baseline in vital sign values | up to Day 35 for each cohort |
| Cohorts 1-3: Number of participants with any adverse event (AE) and any serious adverse event (SAE) | up to Day 21 for each cohort |
| Cohorts 1-3: Number of participants with a mild, moderate, and severe score in local tolerability assessments (LTAs) | up to Day 21 for each cohort |
| Cohorts 1-3: Number of participants with any clinically significant change from baseline in clinical laboratory parameter values | up to Day 21 for each cohort |
| Cohorts 1-3: Number of participants with any clinically significant change from baseline in vital sign values | up to Day 21 for each cohort |
| Cohorts 1-3: Number of participants with any clinically significant change from baseline in electrocardiogram (ECG) findings | up to Day 14 for each cohort |
| Cohort 4: Number of participants with any AE and any SAE | up to Day 35 |
| Cohort 5: Number of participants with any AE and any SAE | up to Day 42 |
| Cohort 4: Number of participants with a mild, moderate, and severe score in LTAs | up to Day 35 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 4: Plasma concentration of BOS-356 | up to Day 35 | Days 1 and 14: pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours post AM dose. Days 2, 7, and 15: pre-dose; 1 and 2 hours post AM dose. Day 28: pre-dose; 1, 2, 4, 6, and 8 hours post AM dose. Follow-Up visit (Day 35) (or end-of-treatment, if applicable): at time of visit |
| Cohort 5: Plasma concentration of BOS-356 | up to Day 35 | Day 1: pre-dose. Days 7, 14, and 28 pre-dose (approximately 12 hours \[± 4 hours\] from the previous dose. Follow-Up visit (Day 35): at time of visit |
| Cohorts 1-3: Plasma concentration of BOS-356 | up to Day 21 for each cohort | Days 1 and 14: pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours post morning (AM) dose. Days 2 and 7: pre-dose; 1 and 2 hours post AM dose. Day 15: 24 hours (± 2 hours) post last dose. Follow-Up visit (Day 21) (or end-of-treatment, if applicable): at time of visit |
Countries
Canada, United States
Outcome results
None listed