Atopic DermatitisPhase 2NCT03824405
Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis
A Phase 2 study testing BTX 1204 in people with Atopic Dermatitis, run by Botanix Pharmaceuticals at 31 sites in 3 countries.
Trial summary
This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- BTX 1204
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 31 sitesin 3 countries
- Study dates
- 4 Feb 2019to 4 Mar 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is of either gender between 12 and 70 years of age, inclusive.
- Subject (or parent/legal guardian) has the ability and willingness to sign a written informed consent.
- Subject has a diagnosis of chronic (≥1 year), stable atopic dermatitis (AD)
- Subject has ≥ 5% and ≤ 30% body surface area (BSA) of AD involvement excluding the scalp and groin.
- Subject has an Investigator's Global Assessment (IGA) score of moderate (3) atopic dermatitis on the 5-point IGA (0-4) scale.
- For selected photography sites, subject has a target lesion of 25 to 200 cm2 in surface area on the trunk, upper extremities or lower extremities with a Baseline Signs of AD score of ≥ 6 and ≤ 12.
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- Subject is in good general health without clinically significant hematological, 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.
- Male subjects and their partners must agree and commit to use a barrier method of contraception throughout the study and for 90 days after last study drug application.
- A negative urine pregnancy test result for all Women of child bearing potential (WOCBP) at the Screening Visit and Baseline Visit.
- Sexually active women must agree to use the following throughout the study and for 30 days after last study drug application. WOCBP who are not sexually active at Baseline and become sexually active must identify a plan for contraception.
- One of these highly effective contraception methods Intrauterine device (IUD); hormonal (injections, implants, transdermal patch, vaginal ring); tubal ligation; partner vasectomy, OR
- Oral contraceptives WITH a barrier method (listed below), OR
- Two barrier forms of contraception (listed below) Male or female condom; diaphragm; cervical cap; contraceptive sponge.
- Males subjects must refrain from sperm donation during the study treatment period and until 90 days after last study drug application.
Who cannot join
- Female subject who is breast feeding, pregnant, or planning to become pregnant.
- Subject who has an IGA score of 2 (mild) or 4 (severe).
- Subject with history of known or suspected intolerance to the drug product excipients.
- Subject has any clinically significant active infection in the investigator's opinion. This includes active impetigo at any AD lesion.
- Subject has known Hepatitis-B, Hepatitis-C, or HIV infection.
- Subject has excessive body or facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of AD.
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- 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 AD lesions.
- Subject has clinically significant or severe allergies that in the investigator's opinion would interfere with participation in the study.
- Subject has known intolerability to topical treatments e.g., reports excessive burning/stinging or pain with use of topical treatments.
- Subject has an active or potentially recurring skin conditions(s) other than AD that in the investigator's opinion would interfere with participation in the study.
- Subject has unstable AD consistent with a requirement for high-potency corticosteroids.
- Subject has used dupilumab (Dupixent) within 12 weeks prior to the Baseline Visit.
- Subject has used any biologic therapy, other than dupilumab, within 28 days prior to the Baseline Visit.
- Subject has used systemic (oral, IV or IM) corticosteroids within 28 days prior to the Baseline Visit. Intra-articular injection for arthroses allowed.
- Subject has used topical anti-pruritics (e.g., PDE4 inhibitors) within 28 days prior to the Baseline Visit.
- If subject is taking oral antihistamines, subject has not been on a stable dose of oral antihistamines within 28 days prior to the Baseline visit.
- Subject has used phototherapy, tanning beds, or any other artificial light device within 28 days prior to the Baseline Visit.
- Subject has used topical corticosteroids within 14 days prior to the Baseline Visit.
- Subject has used topical calcineurin inhibitors within 14 days prior to the Baseline Visit.
- Subjects has used barrier creams (e.g., Mimyx, Atopiclair), within 7 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, acne or rosacea.
- 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 or interfere with the subject's participation in the study. Subjects with other dermatologic conditions, including genetic syndromes that have an eczematous dermatitis as a component of the disease (e.g., Netherton's) are excluded.
- Subject has a clinically relevant history of or current evidence of abuse of alcohol or other drugs.
- 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 participated in another investigational drug or device research study within 30 days of the Screening 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
31 sites in 3 countries.
31 sites in 3 countries
United States19 sites
Dermresearch Inc
Austin, Texas, 78759
J&S Studies Inc.
College Station, Texas, 77845
Precision Clinical Research
Davie, Florida, 33328
Aventiv Research Inc - Dublin
Dublin, Ohio, 43016
T. Joseph Raoff MD Inc. / Encino Research Center
Encino, California, 91436
Center for Dermatology Clinical Research
Fremont, California, 94538
Greenville Dermatology, LLC
Greenville, South Carolina, 29607
The Center for Skin Research at Suzanne Bruce & Associates Dermatology
Houston, Texas, 77056
JDR Dermatology Research LLC
Las Vegas, Nevada, 89148
Applied Research Center of Arkansas Inc.
Little Rock, Arkansas, 72212
DS Research
Louisville, Kentucky, 40241
The Acne Treatment and Research Center
Morristown, New Jersey, 07960
Dermatology Specialist Inc. - Murrieta
Murrieta, California, 92562
Delright Research
New Orleans, Louisiana, 70115
Troy Sullivan
North Miami Beach, Florida, 33162
Medisearch Clinical Trails
Saint Joseph, Missouri, 64506
Rady Childern's Hospital - San Diego
San Diego, California, 92123
Clinical Science Institute
Santa Monica, California, 90404
Washington Univerisy in St. Louis
St Louis, Missouri, 63141
Australia9 sites
CMAX Clincial Research
Adelaide, 5000
BurwoodDermatology
Burwood, 6100
Sinclair Dermatology
East Melbourne, 3002
North Eastern Health Specialists
Hectorville, 5073
Premier Specialists PTY LTD
Kogarah, 2217
St George Dermatology & Skin Cancer Center
Kogarah, 2217
Captain Stirling Medical Centre
Nedlands, 6009
The Skin Hospital
Westmead, 2145
Veracity Clinical Research
Woolloongabba, 4102
New Zealand3 sites
Optimal Clinical Trials
Auckland, 1010
Clinical Trials New Zealand LTD
Hamilton, 3204
P3 Research
Wellington, 6021
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis
This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD.
Read the detailed description
This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD. Eligible subjects will be enrolled and randomized to treatment with BTX 1204 or Vehicle for 84 days. Approximately two hundred (200) subjects will be enrolled. Subjects will receive BID application of study drug for 84 days with a final application on the evening of Day 84 for a total of 168 doses.
- Conditions
- Atopic Dermatitis
- Being tested
- BTX 1204, Vehicle
- Keywords
- CBD, Synthetic CBD, Cannabidiol
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTX 1204Drug
BTX 1204 liquid formulation
VehicleDrug
Vehicle liquid formulation
| Study group | Role | What they receive |
|---|---|---|
| BTX 1204 | Active comparator | BTX 1204 twice daily Receives: Drug: BTX 1204 |
| Vehicle | Placebo comparator | Vehicle twice daily Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment (IGA)
Investigator's Global Assessment (IGA) success defined as an IGA score of "Clear" (0) or "Almost Clear" (1) with at least a 2-grade improvement
Measured: Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start4 Feb 2019
- Primary completion27 Jan 2020
- Study completion4 Mar 2020
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 Atopic DermatitisStudies 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
- 200 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
- NCT03824405
- Sponsor's protocol ID
- BTX.2018.003
- Status last verified
- Sep 2022
- First submitted
- 29 Jan 2019
- Last updated
- 25 Oct 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 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03824405
- Acronym / sponsor ID
- BTX.2018.003
- Conditions
- Atopic Dermatitis
- Keywords
- CBD, Synthetic CBD, Cannabidiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Botanix PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 27 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD.
Detailed description
This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD. Eligible subjects will be enrolled and randomized to treatment with BTX 1204 or Vehicle for 84 days. Approximately two hundred (200) subjects will be enrolled. Subjects will receive BID application of study drug for 84 days with a final application on the evening of Day 84 for a total of 168 doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTX 1204 | Active comparator | Drug: BTX 1204BTX 1204 twice daily |
| Vehicle | Placebo comparator | Drug: VehicleVehicle twice daily |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Subject is of either gender between 12 and 70 years of age, inclusive.
- Subject (or parent/legal guardian) has the ability and willingness to sign a written informed consent.
- Subject has a diagnosis of chronic (≥1 year), stable atopic dermatitis (AD)
- Subject has ≥ 5% and ≤ 30% body surface area (BSA) of AD involvement excluding the scalp and groin.
- Subject has an Investigator's Global Assessment (IGA) score of moderate (3) atopic dermatitis on the 5-point IGA (0-4) scale.
Key exclusion criteria (27 listed)
- Female subject who is breast feeding, pregnant, or planning to become pregnant.
- Subject who has an IGA score of 2 (mild) or 4 (severe).
- Subject with history of known or suspected intolerance to the drug product excipients.
- Subject has any clinically significant active infection in the investigator's opinion. This includes active impetigo at any AD lesion.
- Subject has known Hepatitis-B, Hepatitis-C, or HIV infection.
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 1204BTX 1204 liquid formulation | Drug | BTX 1204 |
| VehicleVehicle liquid formulation | Drug | Vehicle |
Primary outcome
Investigator's Global Assessment (IGA)
Time frame: Day 85
Investigator's Global Assessment (IGA) success defined as an IGA score of "Clear" (0) or "Almost Clear" (1) with at least a 2-grade improvement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BTX 1204 in people with Atopic Dermatitis, run by Botanix Pharmaceuticals at 31 sites in 3 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 16 inclusion and 27 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 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Australia, New Zealand. 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 27 Sep 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?
Investigator's Global Assessment (IGA) (time frame: Day 85). 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 25 Oct 2022.