Moderate to Severe Acne VulgarisPhase 1NCT04163263

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

A Phase 1 study testing BOS-356 in people with Moderate to Severe Acne Vulgaris, run by Boston Pharmaceuticals at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Moderate to Severe Acne Vulgaris
What is being tested?: BOS-356
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 7 sitesin 2 countries
Study dates: 4 Nov 2019to 11 Nov 2020
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 29Show fewer

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 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.

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

United States6 sites

DermResearch, Inc.
Austin, Texas, 78759
J&S Studies, Inc.
College Station, Texas, 77845
Center for Dermatology Clinical Research
Fremont, California, 94538
Dermatology Consulting Services
High Point, North Carolina, 27262
Progressive Clinical Research
San Antonio, Texas, 78213
International Clinical Research
Sanford, Florida, 32771

Other trials in United States

Canada1 site

Innovaderm Research, Inc.
Montreal

Other trials in Canada

About this study

Official title: Phase 1, Randomized, Vehicle-Controlled, Double-Blind 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

Read the 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.

Conditions: Moderate to Severe Acne Vulgaris
Being tested: BOS-356, Vehicle
Keywords: BOS-356, acne
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BOS-356Drug
topical gel
VehicleDrug
topical gel

Study groups in NCT04163263
Study group	Role	What they receive
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 Receives: Drug: BOS-356
Cohorts 1-3: Vehicle	Placebo comparator	Twice daily application of vehicle gel Receives: 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 Receives: Drug: BOS-356
Cohort 4: Vehicle	Placebo comparator	Twice daily application of vehicle gel Receives: 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 Receives: Drug: BOS-356
Cohort 5: Vehicle	Placebo comparator	Twice daily application of vehicle gel Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohorts 1-3: Number of participants with any adverse event (AE) and any serious adverse event (SAE)
Measured: 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)
Measured: 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
Measured: up to Day 21 for each cohort
Cohorts 1-3: Number of participants with any clinically significant change from baseline in vital sign values
Measured: up to Day 21 for each cohort
Cohorts 1-3: Number of participants with any clinically significant change from baseline in electrocardiogram (ECG) findings
Measured: up to Day 14 for each cohort
Cohort 4: Number of participants with any AE and any SAE
Measured: up to Day 35
Cohort 5: Number of participants with any AE and any SAE
Measured: up to Day 42
Cohort 4: Number of participants with a mild, moderate, and severe score in LTAs
Measured: up to Day 35
Cohort 5: Number of participants with a mild, moderate, and severe score in LTAs
Measured: up to Day 42
Cohorts 4 and 5: Number of participants with any clinically significant change from baseline in clinical laboratory parameter values
Measured: 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
Measured: up to Day 35 for each cohort
Cohorts 4 and 5: Number of participants with any clinically significant change from baseline in ECG findings
Measured: up to Day 35 for each cohort

Secondary outcomes (3)

Cohorts 1-3: Plasma concentration of BOS-356
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
Measured: up to Day 21 for each cohort
Cohort 4: Plasma concentration of BOS-356
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
Measured: up to Day 35
Cohort 5: Plasma concentration of BOS-356
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
Measured: up to Day 35

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 201911 Nov 2020

First posted14 Nov 2019
Study start4 Nov 2019
Primary completion11 Nov 2020
Study completion11 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Moderate to Severe Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04163263
Sponsor's protocol ID: BOS-356-101
Status last verified: Nov 2020
First submitted: 12 Nov 2019
Last updated: 27 Nov 2020
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
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A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)
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Active, not recruitingPhase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruitingPhase 2/3
A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
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All Moderate to Severe Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1, Randomized, Vehicle-Controlled, Double-Blind 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
ClinicalTrials.gov ID: NCT04163263
Acronym / sponsor ID: BOS-356-101
Conditions: Moderate to Severe Acne Vulgaris
Keywords: BOS-356, acne
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Boston PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 4 Nov 2019 (actual)
Primary completion: 11 Nov 2020 (actual)
Study completion: 11 Nov 2020 (actual)
First posted: 14 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Cohorts 1-3: BOS-356	Experimental	Drug: BOS-356Twice daily application of BOS-356 0.1%, 0.4%, and 0.7% gel in Cohorts 1, 2, and 3, respectively
Cohorts 1-3: Vehicle	Placebo comparator	Drug: VehicleTwice daily application of vehicle gel
Cohort 4: BOS-356	Experimental	Drug: BOS-356Twice daily application of BOS-356 gel at a dose determined based on safety and tolerability data from Cohorts 1-3
Cohort 4: Vehicle	Placebo comparator	Drug: VehicleTwice daily application of vehicle gel
Cohort 5: BOS-356	Experimental	Drug: BOS-356Twice daily application of BOS-356 gel at a dose determined based on safety and tolerability data from Cohorts 1-3
Cohort 5: Vehicle	Placebo comparator	Drug: VehicleTwice daily application of vehicle gel

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (29 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BOS-356topical gel	Drug	Cohort 4: BOS-356, Cohort 5: BOS-356, Cohorts 1-3: BOS-356
Vehicletopical gel	Drug	Cohort 4: Vehicle, Cohort 5: Vehicle, Cohorts 1-3: Vehicle

Primary outcome

Cohorts 1-3: Number of participants with any adverse event (AE) and any serious adverse event (SAE)
Time frame: 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)
Time frame: 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
Time frame: up to Day 21 for each cohort
Cohorts 1-3: Number of participants with any clinically significant change from baseline in vital sign values
Time frame: up to Day 21 for each cohort
Cohorts 1-3: Number of participants with any clinically significant change from baseline in electrocardiogram (ECG) findings
Time frame: up to Day 14 for each cohort
Cohort 4: Number of participants with any AE and any SAE
Time frame: up to Day 35
Cohort 5: Number of participants with any AE and any SAE
Time frame: up to Day 42
Cohort 4: Number of participants with a mild, moderate, and severe score in LTAs
Time frame: up to Day 35
Cohort 5: Number of participants with a mild, moderate, and severe score in LTAs
Time frame: up to Day 42
Cohorts 4 and 5: Number of participants with any clinically significant change from baseline in clinical laboratory parameter values
Time frame: 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
Time frame: up to Day 35 for each cohort
Cohorts 4 and 5: Number of participants with any clinically significant change from baseline in ECG findings
Time frame: up to Day 35 for each cohort

3 secondary outcomes

Cohorts 1-3: Plasma concentration of BOS-356
Time frame: up to Day 21 for each cohort
Cohort 4: Plasma concentration of BOS-356
Time frame: up to Day 35
Cohort 5: Plasma concentration of BOS-356
Time frame: up to Day 35

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
Individual participant dataSharing planned: No

Related trials for Moderate to Severe Acne Vulgaris

RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Active, not recruitingPhase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)
Hidradenitis Suppurativa
Active, not recruitingPhase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruitingPhase 2/3
A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BOS-356 in people with Moderate to Severe Acne Vulgaris, run by Boston Pharmaceuticals at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohorts 1-3: Number of participants with any adverse event (AE) and any serious adverse event (SAE) (time frame: up to Day 21 for each cohort). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04163263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.