Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Repeat Topical Application of BOS-356 in Subjects With Moderate to Severe Acne Vulgaris

NCT04163263 | Completed Phase 1 FDA Drug

• 1 other identifier: BOS-356-101
• Study Type: interventional
• Target: 66
• Locations: 2 countries
• Sites: 7

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

Conditions

Moderate to Severe Acne Vulgaris

Keywords

BOS-356; acne

Outcome Measures

Primary Outcomes (12)

• 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

• 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 4 and 5: Number of participants with any clinically significant change from baseline in ECG findings

  up to Day 35 for each cohort

Secondary Outcomes (3)

• Cohorts 1-3: Plasma concentration of BOS-356

  up to Day 21 for each cohort

• Cohort 4: Plasma concentration of BOS-356

  up to Day 35

• Cohort 5: Plasma concentration of BOS-356

  up to Day 35

Study Arms (6)

Cohorts 1-3: BOS-356

EXPERIMENTAL

Twice daily application of BOS-356 0.1%, 0.4%, and 0.7% gel in Cohorts 1, 2, and 3, respectively

Drug: BOS-356

Cohorts 1-3: Vehicle

PLACEBO COMPARATOR

Twice daily application of vehicle gel

Drug: Vehicle

Cohort 4: BOS-356

EXPERIMENTAL

Twice daily application of BOS-356 gel at a dose determined based on safety and tolerability data from Cohorts 1-3

Drug: BOS-356

Cohort 4: Vehicle

PLACEBO COMPARATOR

Twice daily application of vehicle gel

Drug: Vehicle

Cohort 5: BOS-356

EXPERIMENTAL

Twice daily application of BOS-356 gel at a dose determined based on safety and tolerability data from Cohorts 1-3

Drug: BOS-356

Cohort 5: Vehicle

PLACEBO COMPARATOR

Twice daily application of vehicle gel

Drug: Vehicle

Interventions

BOS-356 DRUG

topical gel

Cohort 4: BOS-356; Cohort 5: BOS-356; Cohorts 1-3: BOS-356

Vehicle DRUG

topical gel

Cohort 4: Vehicle; Cohort 5: Vehicle; Cohorts 1-3: Vehicle

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Boston Pharmaceuticals: lead

Study Sites (7)

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

International Clinical Research

Sanford, Florida, 32771, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Innovaderm Research, Inc.

Montreal, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 14, 2019
• Study Start: November 4, 2019
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (6)