Acne VulgarisPhase 2NCT03573518
Evaluation of BTX 1503 in Patients With Moderate to Severe Acne Vulgaris
A Phase 2 study testing BTX 1503 in people with Acne Vulgaris, run by Botanix Pharmaceuticals at 36 sites in 2 countries.
Trial summary
The objective of this study is to assess safety and efficacy of various doses of BTX 1503 liquid formulation in subjects with moderate to severe acne vulgaris of the face. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- BTX 1503
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 26 Jun 2018to 5 Sep 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject (or legal guardian) has the ability and willingness to sign a written informed consent/assent.
- Subject is of either gender and 12 to 40 years of age.
- Subject is in good general health without clinically significant haematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the investigator.
- Subject has suitable venous access for blood sampling.
- Subject is able and willing to complete the study and to comply with all study instructions and attend the necessary visits.
- Subject has acne vulgaris of the face defined as:
Show all 19Show fewer
- 20 to 50 (inclusive) inflammatory lesions on the face
- 20 to 100 (inclusive) non-inflammatory lesions on the face
- An Investigator's Global Assessment (IGA) score for acne severity of 3 or 4 (moderate or severe) assessed on the face.
- Subject has ≤ 2 nodular/cystic acne lesions (>5 mm in diameter).
- Subject must refrain from the use of other treatments for acne during the study.
- Subject must agree to not wash or shave their face, swim or otherwise get their face wet for at least 1 hour after application of study medication.
- Subject must agree to maintain their regular use of sunscreens, moisturizers, shaving cream, and facial make up throughout the entire course of the study.
- Male subjects and their partners must agree and commit to use a barrier method of contraception during the study and for 90 days after last study drug application.
- A negative UPT result for all WOCBP at the Screening Visit and Baseline Visit, if applicable. A WOCBP is one who is not permanently sterilized or is not postmenopausal. Postmenopausal is defined as 24 months with no menses without an alternative medical cause.
- Sexually active women must agree to use the following throughout the study and for 30 days after last study drug application:
- One of these highly effective contraception methods i. Intrauterine device (IUD); hormonal (injections, implants, transdermal patch, vaginal ring; tubal ligation; partner vasectomy, OR b. Oral contraceptives WITH a barrier method (listed below), OR c. Two barrier forms of contraception (listed below) i. Male or female condom; diaphragm; cervical cap.
- Male subjects must refrain from sperm donation during the study treatment period until 90 days after final study drug administration.
- Male subjects must agree to keep their face clean shaven (no moustache or goatee; short sideburns acceptable) throughout the study and use the same method for shaving as was used for the 4 weeks prior to the Screening Visit.
Who cannot join
- People who would otherwise qualify for the study but are living in the same household as a study subject, are not allowed to participate in the study.
- Female subject who is breast feeding, pregnant, or planning to become pregnant any time during the course of the study.
- Subject with history of known or suspected intolerance to the drug product excipients.
- Subject has known HIV infection.
- Subject has acne conglobata, acne fulminans, secondary acne (chloracne), pseudo-folliculitis, severe acne requiring systemic treatment, or is taking a medication known to induce or exacerbate acne.
- Subject has severe truncal acne.
Show all 32Show fewer
- Subject has excessive facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of acne vulgaris.
- Subject has sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality that would result in the inability to evaluate the skin of the face.
- Subject has any skin condition of the face other than acne vulgaris.
- Subject has used oral retinoid (e.g. isotretinoin) within 6 months (180 days) prior to the Baseline Visit.
- Subject has used Vitamin A supplements greater than 10,000 units/day within 6 months (180 days) prior to the Baseline Visit.
- Subject has used androgen receptor blockers (such as spironolactone or flutamide) within 3 months (90 days) prior to the Baseline Visit.
- Subject has initiated treatment with hormonal therapy or changed dosing with hormonal therapy within 3 months (90 days) prior to the Baseline Visit.
- Subject has had facial procedures (chemical or laser peel, microdermabrasion, etc.) within 8 weeks (56 days) prior to the Baseline Visit.
- Subject has had treatment with systemic antibiotics within 4 weeks (28 days) prior to the Baseline Visit.
- Subject has had treatment with systemic anti-acne drugs within 4 weeks (28 days) prior to the Baseline Visit.
- Subject has had treatment with systemic anti-inflammatory drugs within 4 weeks (28 days) prior to the Baseline Visit.
- Subject has had treatment with systemic (oral) corticosteroids other immunosuppressive medications within 4 weeks (28 days) prior to the Baseline Visit.
- Subject has had treatment with prescription topical retinoid use on the face (e.g. tretinoin, tazarotene) within 4 weeks (28 days) prior to the Baseline Visit.
- Subject has had treatment with topical prescription antibiotics (e.g. dapsone, clindamycin, erythromycin, or sulfacetamide) or combination products that include a topical antibiotic within 2 weeks (14 days) prior to the Baseline Visit.
- Subject has had treatment with over-the-counter (OTC) topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti- inflammatory medications, corticosteroids, adapalene, α-hydroxy/glycolic acid on the face within 2 weeks (14 days) prior to the Baseline Visit.
- Subject is currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
- Subject has had photodynamic therapy within 8 weeks (56 days) prior to the Baseline Visit.
- Subject has used a tanning bed within 2 weeks (14 days) prior to the Baseline Visit.
- Subject has used home-based light treatment within 2 weeks (14 days) prior to the Baseline Visit.
- Subject has an underlying disease that requires the use of interfering topical or systemic therapy.
- Subject has other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, psoriasis, perioral dermatitis, or rosacea.
- Subject has had excessive sun exposure (in the opinion of the investigator) within one week prior to the Baseline Visit and an unwillingness to refrain from excessive sun exposure during the study.
- Subject has a clinically relevant history or currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk. This may include respiratory (including chronic asthma requiring repetitive drug interventions), gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
- Subject has a clinically relevant history of, or current evidence of, abuse of alcohol or other drugs. Subjects may be deemed eligible if the UDS identifies subject-reported, prescribed drugs or appropriate levels of alcohol, as determined by the investigator.
- Subject has participated in another investigational drug or device research study within 4 weeks (28 days) of the Baseline Visit or five half-lives of the drug, whichever is longer.
- Any other reason that would make the subject, in the opinion of the investigator or sponsor, unsuitable for the study.
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States25 sites
Avant Research Associates, LLC
Austin, Texas, 78704
DermReasearch
Austin, Texas, 78759
Metro Boston Clinical
Brighton, Maine, 02135
J&S Studies, Inc.
College Station, Texas, 77845
Aventiv Research
Dublin, Ohio, 43016
Encino Research Center
Encino, California, 91436
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Greenville Dermatology, LLC
Greenville, South Carolina, 29607
Penn State Hershey Medical
Hershey, Pennsylvania, 17033
Suzanne Bruce and Associates, PA
Houston, Texas, 77056
Clinical Partners, LLC
Johnston, Rhode Island, 02919
JDR Dermatology Research
Las Vegas, Nevada, 89148
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
DS Research - Louisville
Louisville, Kentucky, 40241
Well Phrama Medical Research
Miami, Florida, 33143
The Acne Treatment and Research Center
Morristown, New Jersey, 07960
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Dermatology Specialist, Inc.
Murrieta, California, 92562
Delricht Research
New Orleans, Louisiana, 70115
Tory Sullivan, M.D., PA
North Miami Beach, Florida, 33162
Quest Dermatology Research
Northridge, California, 91324
Medisearch Clinical Trials
Saint Joseph, Missouri, 64506
Clinical Science Insitute
Santa Monica, California, 90404
Washington University School of Medicine - Dermatology
St Louis, Missouri, 63141
Precision Clinical Research
Sunrise, Florida, 33351
Australia11 sites
Cmax Clinical Research
Adelaide, 5000
The Skin Centre
Benowa, 4217
Burswood Dermatology
Burwood, 6100
Skin & Canver Foundation Inc.
Carlton, 053
Sinclair Dermatology
East Melbourne, 3002
Fremantle Dermatology
Fremantle, 6160
North Eastern Health Specialist
Hectorville, 5073
St George Dermatology & Skim Cancer Center
Kogarah, 2217
Captain Sterline Medical Centre
Nedlands, 6009
Woden Dermatology
Phillip, 2606
Varacity Clinical Research
Woolloongabba, 4102
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of BTX 1503 in Patients With Moderate to Severe Acne Vulgaris
The objective of this study is to assess safety and efficacy of various doses of BTX 1503 liquid formulation in subjects with moderate to severe acne vulgaris of the face.
Read the detailed description
This will be a multi-center, randomized, double-blinded, vehicle-controlled, parallel group, dose-finding study in pediatrics, adolescents and adults (aged 12 to 40 years). The objective of this study is to assess the safety and efficacy of various doses of BTX 1503 in subjects with moderate to severe acne vulgaris of the face.
- Conditions
- Acne Vulgaris
- Being tested
- BTX 1503, Vehicle
- Keywords
- Synthetic CBD, Cannabidiol
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTX 1503Drug
Also called BTX1503
BTX 1503 Dose 1 liquid formulation, or BTX 1503 Dose 2 liquid formulation
VehicleDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BTX 1503 5% BID | Experimental | BTX 1503 5% CBD (w/w) solution twice daily Receives: Drug: BTX 1503 |
| BTX 1503 5% QD | Experimental | BTX 1503 5% CBD (w/w) solution once daily Receives: Drug: BTX 1503 |
| BTX 1503 2.5% QD | Experimental | BTX 1503 2.5% CBD (w/w) solution once daily Receives: Drug: BTX 1503 |
| Vehicle BID | Placebo comparator | Vehicle twice daily Receives: Drug: Vehicle |
| Vehicle QD | Placebo comparator | Vehicle once daily Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as Measured by Reported Adverse Events
Summary of Treatment-Emergent Adverse Events by MedDra Preferred Term that Occurred with a Frequency > 2% in any Treatment Group (Safety Population)
Measured: Day 84
Secondary outcomes (1)
Absolute Change From Baseline in Inflammatory Lesion Counts
Summary of Absolute Change from Baseline in Inflammatory Count at Day 84 (Intent-to-Treat Population)
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start26 Jun 2018
- Primary completion16 Aug 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botanix Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Robinson, CRNP, Study director, Head of Development, Botanix Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573518
- Sponsor's protocol ID
- BTX.2018.001
- Status last verified
- Apr 2022
- First submitted
- 19 Jun 2018
- Last updated
- 18 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of BTX 1503 in Patients With Moderate to Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03573518
- Acronym / sponsor ID
- BTX.2018.001
- Conditions
- Acne Vulgaris
- Keywords
- Synthetic CBD, Cannabidiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Botanix PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Posted 18 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess safety and efficacy of various doses of BTX 1503 liquid formulation in subjects with moderate to severe acne vulgaris of the face.
Detailed description
This will be a multi-center, randomized, double-blinded, vehicle-controlled, parallel group, dose-finding study in pediatrics, adolescents and adults (aged 12 to 40 years). The objective of this study is to assess the safety and efficacy of various doses of BTX 1503 in subjects with moderate to severe acne vulgaris of the face.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BTX 1503 5% BID | Experimental | Drug: BTX 1503BTX 1503 5% CBD (w/w) solution twice daily |
| BTX 1503 5% QD | Experimental | Drug: BTX 1503BTX 1503 5% CBD (w/w) solution once daily |
| BTX 1503 2.5% QD | Experimental | Drug: BTX 1503BTX 1503 2.5% CBD (w/w) solution once daily |
| Vehicle BID | Placebo comparator | Drug: VehicleVehicle twice daily |
| Vehicle QD | Placebo comparator | Drug: VehicleVehicle once daily |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- Subject (or legal guardian) has the ability and willingness to sign a written informed consent/assent.
- Subject is of either gender and 12 to 40 years of age.
- Subject is in good general health without clinically significant haematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the investigator.
- Subject has suitable venous access for blood sampling.
- Subject is able and willing to complete the study and to comply with all study instructions and attend the necessary visits.
Key exclusion criteria (32 listed)
- People who would otherwise qualify for the study but are living in the same household as a study subject, are not allowed to participate in the study.
- Female subject who is breast feeding, pregnant, or planning to become pregnant any time during the course of the study.
- Subject with history of known or suspected intolerance to the drug product excipients.
- Subject has known HIV infection.
- Subject has acne conglobata, acne fulminans, secondary acne (chloracne), pseudo-folliculitis, severe acne requiring systemic treatment, or is taking a medication known to induce or exacerbate acne.
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 |
|---|---|---|
| BTX 1503Also: BTX1503BTX 1503 Dose 1 liquid formulation, or BTX 1503 Dose 2 liquid formulation | Drug | BTX 1503 2.5% QD, BTX 1503 5% BID, BTX 1503 5% QD |
| VehiclePlacebo | Drug | Vehicle BID, Vehicle QD |
Primary outcome
Safety as Measured by Reported Adverse Events
Time frame: Day 84
Summary of Treatment-Emergent Adverse Events by MedDra Preferred Term that Occurred with a Frequency > 2% in any Treatment Group (Safety Population)
1 secondary outcome
Absolute Change From Baseline in Inflammatory Lesion Counts
Time frame: Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Anthony Robinson, CRNP study director
Head of Development, Botanix Pharmaceuticals
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BTX 1503 in people with Acne Vulgaris, run by Botanix Pharmaceuticals at 36 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 19 inclusion and 32 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 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety as Measured by Reported Adverse Events (time frame: Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2022.