Contact DermatitisPhase 1BBINCT03089775

Evaluation of Safety and Efficacy of BBI-2000 in Treating and Preventing Contact Dermatitis

A Phase 1 study testing BBI-2000 and Multiple treatments in people with Contact Dermatitis, run by Fresh Tracks Therapeutics, Inc. at 1 site in Canada.

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 two cohort study (Cohort A and B) is being conducted to assess the safety and efficacy of BBI-2000 for the prevention (Cohort A) and treatment (Cohort B) of delayed type hypersensitivity reaction. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Contact Dermatitis
What is being tested?: BBI-2000 and Multiple treatments
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 1 siteCanada
Study dates: 14 Mar 2017to 24 May 2017
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Individuals aged 18 to 65 years inclusive at the time of consent, and either female of non-reproductive potential or male.
Subjects must be healthy, normal volunteers per physical exam, laboratory and EKG assessments

Who cannot join

History of contact dermatitis to medical adhesive bandages or glue.
Medical history of dermatographism.
Any medical condition causing immunosuppression.
Prior treatment or therapies or history of sensitivity to any of the study products.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5

Other trials in Canada

About this study

Official title: A Randomized, Controlled Study to Evaluate the Effect of Topically Applied BBI-2000 (5%) on Allergic Responses in Subjects With Contact Hypersensitivity to Diphencyprone

Read the detailed description

This two cohort (Cohort A and B) single-center, randomized, controlled study is being conducted to evaluate the safety and efficacy of BBI-2000 for the prevention (Cohort A) and treatment (Cohort B) of delayed type hypersensitivity (DTH) reactions.

Subjects in Cohort A will initially receive either pre-treatment with BBI-2000 or vehicle, on an area on the back. Diphencyprone (DPCP) will then be administered, via Finn chamber, to the same area on the back. The treated area will then be assessed to determine if BBI-2000 was effective in preventing a contact hypersensitivity reaction.

Cohort B will first be sensitized with DPCP as in Cohort A. Indicated regions of the back will then be challenged to illicit a DTH reaction. Following the challenge, indicated regions on the subject's back will be treated with either (A) BBI-2000, (B) vehicle, (C) no topical application or (D) clobetasol propionate. The efficacy of BBI-2000 will be evaluated by monitoring response of the area of contact hypersensitivity reaction.

Conditions: Contact Dermatitis
Being tested: BBI-2000, Vehicle, Multiple treatments
Keywords: Contact, Treatment, Prevention, BBI-2000, Dermatitis, Allergic
Medical subject headings: Dermatitis, Contact, Dermatitis

What participants receive

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

BBI-2000Drug
Experimental
VehicleDrug
Vehicle Comparator
Multiple treatmentsOther
BBI-2000, Vehicle, Clobetasol Propionate, No treatment

Study groups in NCT03089775
Study group	Role	What they receive
BBI-2000	Experimental	Cohort A Receives: Drug: BBI-2000
Vehicle	Placebo comparator	Cohort A Receives: Drug: Vehicle
Multiple treatments	Other	Cohort B Receives: Drug: BBI-2000; Drug: Vehicle; Other: Multiple treatments

What is being measured

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

Number of adverse events in each study group
Comparison of the number and severity of adverse event between study groups
Measured: 4 weeks
Vital signs, physical examinations, ECG, blood analysis, urine analysis
Changes in vital signs, physical examinations, ECG, blood and urine analyses between study groups
Measured: 4 weeks
Size of contact hypersensitivity reaction
Mean diameter (mm) of the contact hypersensitivity reaction induced by DPCP for subjects randomized to BBI-2000 (5%) as compared with vehicle
Measured: 4 weeks

Secondary outcomes (2)

Dermal thickness
Contact hypersensitivity reactions will be quantified using a high-frequency 20-Megahertz (MHz) ultrasound scanner
Measured: 4 weeks
Diameter (mm) of the contact hypersensitivity area
Mean diameter (mm) of the contact hypersensitivity reaction induced by DPCP for areas randomized to BBI-2000, as compared with vehicle, no treatment, and clobetasol propionate over time
Measured: 4 weeks

Timeline

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

14 Mar 201724 May 2017

First posted24 Mar 2017
Study start14 Mar 2017
Primary completion24 May 2017
Study completion24 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Contact 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03089775
Sponsor's protocol ID: BBI-2000-CL-101
Acronym: BBI
Status last verified: Jul 2017
First submitted: 15 Mar 2017
Last updated: 17 Jul 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
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

Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Not yet recruiting
Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
Allergic Contact Dermatitis (ACD)
Recruiting
Glycyrrhetinic Acid and Acute Irritant Dermatitis
Irritant Contact Dermatitis
Recruiting
Exploring Skin Barrier Function, Recurrence of Diabetes Device-Related Contact Dermatitis, and Evaluation of Hydrocolloid and Silicone-Based Patches for Its Prevention in Children and Adolescents With Type 1 Diabetes
Contact Dermatitis, Type 1 Diabetes Mellitus
Not yet recruitingPhase 4
Reliability of Expired Allergens in Patch Testing: A Comparative Study With Non-Expired Series
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All Contact Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled Study to Evaluate the Effect of Topically Applied BBI-2000 (5%) on Allergic Responses in Subjects With Contact Hypersensitivity to Diphencyprone
ClinicalTrials.gov ID: NCT03089775
Acronym / sponsor ID: BBI / BBI-2000-CL-101
Conditions: Contact Dermatitis
Keywords: Contact, Treatment, Prevention, BBI-2000, Dermatitis, Allergic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Fresh Tracks Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 14 Mar 2017 (actual)
Primary completion: 24 May 2017 (actual)
Study completion: 24 May 2017 (actual)
First posted: 24 Mar 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
BBI-2000	Experimental	Drug: BBI-2000Cohort A
Vehicle	Placebo comparator	Drug: VehicleCohort A
Multiple treatments	Other	Drug: BBI-2000, Drug: Vehicle, Other: Multiple treatmentsCohort B

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Individuals aged 18 to 65 years inclusive at the time of consent, and either female of non-reproductive potential or male.
Subjects must be healthy, normal volunteers per physical exam, laboratory and EKG assessments

Key exclusion criteria (4 listed)

History of contact dermatitis to medical adhesive bandages or glue.
Medical history of dermatographism.
Any medical condition causing immunosuppression.
Prior treatment or therapies or history of sensitivity to any of the study products.

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
BBI-2000Experimental	Drug	BBI-2000, Multiple treatments
VehicleVehicle Comparator	Drug	Multiple treatments, Vehicle
Multiple treatmentsBBI-2000, Vehicle, Clobetasol Propionate, No treatment	Other	Multiple treatments

Primary outcome

Number of adverse events in each study group
Time frame: 4 weeks
Comparison of the number and severity of adverse event between study groups
Vital signs, physical examinations, ECG, blood analysis, urine analysis
Time frame: 4 weeks
Changes in vital signs, physical examinations, ECG, blood and urine analyses between study groups
Size of contact hypersensitivity reaction
Time frame: 4 weeks
Mean diameter (mm) of the contact hypersensitivity reaction induced by DPCP for subjects randomized to BBI-2000 (5%) as compared with vehicle

2 secondary outcomes

Dermal thickness
Time frame: 4 weeks
Diameter (mm) of the contact hypersensitivity area
Time frame: 4 weeks

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 17 Jul 2017.
Individual participant dataSharing planned: No

Related trials for Contact Dermatitis

Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Not yet recruiting
Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
Allergic Contact Dermatitis (ACD)
Recruiting
Glycyrrhetinic Acid and Acute Irritant Dermatitis
Irritant Contact Dermatitis
Recruiting
Exploring Skin Barrier Function, Recurrence of Diabetes Device-Related Contact Dermatitis, and Evaluation of Hydrocolloid and Silicone-Based Patches for Its Prevention in Children and Adolescents With Type 1 Diabetes
Contact Dermatitis, Type 1 Diabetes Mellitus
Not yet recruitingPhase 4
Reliability of Expired Allergens in Patch Testing: A Comparative Study With Non-Expired Series
Allergic Contact Dermatitis

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.

Lawrence A Romel, MS study director

Fresh Tracks Therapeutics, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BBI-2000 and Multiple treatments in people with Contact Dermatitis, run by Fresh Tracks Therapeutics, Inc. at 1 site in Canada.

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 2 inclusion and 4 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 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

Number of adverse events in each study group (time frame: 4 weeks). 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?

On the ClinicalTrials.gov record for NCT03089775.

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 17 Jul 2017.