PsoriasisPhase 2NCT03381625
Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
A Phase 2 study testing BMX-010 in people with Psoriasis and Atopic Dermatitis, run by BioMimetix JV, LLC at 10 sites in United States.
Trial summary
This is a randomized, placebo-controlled Phase 2 trial consisting of up to 300 subjects with either psoriasis or atopic dermatitis. In this trial BMX-010 will be topically applied twice daily for up to 28 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Atopic Dermatitis
- What is being tested?
- BMX-010
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 10 sitesUnited States
- Study dates
- 2 Jan 2018to 24 Jul 2021
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of either atopic dermatitis or psoriasis with mild to moderate lesions involving 1% - 25% of total body surface area
- Candidate for topical treatment of atopic dermatitis or psoriasis
- Negative pregnancy test for females of childbearing potential
Who cannot join
- Systemic pharmacotherapy or phototherapy for treatment of atopic dermatitis or psoriasis
- Erythrodermic, guttate or generalized pustular psoriasis
- Treatment of systemic retinoids, corticosteroids or immunosuppressive agents within 4 weeks of baseline visit
- Treatment with high potency topical steroids, vitamin D analogs, keratolytics, coal tar, phototherapy, calcineurin inhibitors, or antihistamines within 2 weeks of baseline visit
- UV or Dead Sea therapy within 4 weeks of baseline visit
- Treatment with a biologic agent (monoclonal antibody) within 30 days or 5 times its circulating half-life (whichever is longer) prior to baseline visit
Show all 14Show fewer
- Atopic dermatitis triggered by environmental allergen or irritant
- Contact dermatitis or drug-induced skin reactions
- Systemic or skin infection requiring antimicrobial therapy
- Systemic chemotherapy or radiotherapy within 4 weeks of baseline visit
- Immunocompromise of any cause
- Pregnancy, lactation or inadequate contraception
- Active drug or alcohol dependence
- Significant acute or chronic medical, neurological or psychiatric illness that would compromise subject's safety
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Apex Dermatology
Denver, Colorado, 80230
Encino Research Center
Encino, California, 91436
Colorado Skin Care
Englewood, Colorado, 80113
AboutSkin Dermatology & DermSurgery
Greenwood Village, Colorado, 80111
Presicion Research Institute
Houston, Texas, 77029
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, 46256
Dermatology Associates of Nashville
Knoxville, Tennessee, 37917
Ciocca Dermatology
Miami, Florida, 33173
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Juva Skin & Laser Center
New York, New York, 10022
About this study
Official title: A Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety, Clinical Effects, and Systemic Exposure of a Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
This is a randomized, placebo-controlled Phase 2 trial consisting of up to 300 subjects with either psoriasis or atopic dermatitis. In this trial BMX-010 will be topically applied twice daily for up to 28 days.
Read the detailed description
This is a Phase 2, randomized, multicenter, placebo-controlled study sponsored by BioMimetix JV, LLC (BMX). It is a double-blind parallel cohort study designed to determine the safety and efficacy of BMX-010 (0.03%) relative to Placebo in subjects with atopic dermatitis and psoriasis.
Subjects will be queried regarding adverse events (AEs) and concomitant medication usage.
- Conditions
- Psoriasis, Atopic Dermatitis
- Being tested
- BMX-010, Placebo
- Medical subject headings
- Psoriasis, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMX-010Drug
Safety and efficacy of BMX-010 in topical treatment of psoriasis and/or atopic dermatitis.
PlaceboDrug
Topical administration of placebo in patients with psoriasis and/or atopic dermatitis.
| Study group | Role | What they receive |
|---|---|---|
| BMX-010 0.03% | Experimental | 200 subjects will receive BMX-010 0.03% twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions. Receives: Drug: BMX-010 |
| Placebo | Placebo comparator | 100 subjects will receive placebo twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions
Assessment of adverse events occurring following topical administration of BMX-010 to atopic dermatitis lesions
Measured: 7-28 days
Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions
Assessment of adverse events occurring following topical administration of BMX-010 to psoriasis lesions
Measured: 7-28 days
Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions
Assessment of efficacy
Measured: 7-28 days
Secondary outcomes (2)
Peak Plasma Concentrations (Cmax) for BMX-010
Measured: 8 days
Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start2 Jan 2018
- Primary completion24 Jul 2021
- Study completion24 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMimetix JV, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381625
- Sponsor's protocol ID
- BMX-DERM-01
- Status last verified
- Oct 2021
- First submitted
- 18 Aug 2016
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety, Clinical Effects, and Systemic Exposure of a Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03381625
- Acronym / sponsor ID
- BMX-DERM-01
- Conditions
- Psoriasis, Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- BioMimetix JV, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 24 Jul 2021 (actual)
- Study completion
- 24 Jul 2021 (actual)
- First posted
- 22 Dec 2017 (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.
This is a randomized, placebo-controlled Phase 2 trial consisting of up to 300 subjects with either psoriasis or atopic dermatitis. In this trial BMX-010 will be topically applied twice daily for up to 28 days.
Detailed description
This is a Phase 2, randomized, multicenter, placebo-controlled study sponsored by BioMimetix JV, LLC (BMX). It is a double-blind parallel cohort study designed to determine the safety and efficacy of BMX-010 (0.03%) relative to Placebo in subjects with atopic dermatitis and psoriasis.
Subjects will be queried regarding adverse events (AEs) and concomitant medication usage.
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 |
|---|---|---|
| BMX-010 0.03% | Experimental | Drug: BMX-010200 subjects will receive BMX-010 0.03% twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions. |
| Placebo | Placebo comparator | Drug: Placebo100 subjects will receive placebo twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of either atopic dermatitis or psoriasis with mild to moderate lesions involving 1% - 25% of total body surface area
- Candidate for topical treatment of atopic dermatitis or psoriasis
- Negative pregnancy test for females of childbearing potential
Key exclusion criteria (14 listed)
- Systemic pharmacotherapy or phototherapy for treatment of atopic dermatitis or psoriasis
- Erythrodermic, guttate or generalized pustular psoriasis
- Treatment of systemic retinoids, corticosteroids or immunosuppressive agents within 4 weeks of baseline visit
- Treatment with high potency topical steroids, vitamin D analogs, keratolytics, coal tar, phototherapy, calcineurin inhibitors, or antihistamines within 2 weeks of baseline visit
- UV or Dead Sea therapy within 4 weeks of baseline visit
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 |
|---|---|---|
| BMX-010Safety and efficacy of BMX-010 in topical treatment of psoriasis and/or atopic dermatitis. | Drug | BMX-010 0.03% |
| PlaceboTopical administration of placebo in patients with psoriasis and/or atopic dermatitis. | Drug | Placebo |
Primary outcome
Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions
Time frame: 7-28 days
Assessment of adverse events occurring following topical administration of BMX-010 to atopic dermatitis lesions
Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions
Time frame: 7-28 days
Assessment of adverse events occurring following topical administration of BMX-010 to psoriasis lesions
Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions
Time frame: 7-28 days
Assessment of efficacy
2 secondary outcomes
Peak Plasma Concentrations (Cmax) for BMX-010
Time frame: 8 days
Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010
Time frame: 8 days
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 5 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMX-010 in people with Psoriasis and Atopic Dermatitis, run by BioMimetix JV, LLC at 10 sites in United States.
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 3 inclusion and 14 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
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?
Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions (time frame: 7-28 days). The study lists 3 primary outcomes in all. 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 5 Oct 2021.