Dermatitis, AtopicPhase 1/2WBI-1001-201NCT00837551
Phase IIa Study of WBI-1001 Cream for Atopic Dermatitis
A Phase 1/2 study testing WBI-1001 in people with Dermatitis, Atopic, run by Welichem Biotech Inc. at 1 site in Canada.
Trial summary
WBI-1001 is a synthetic,new, non-steroid, small molecule being developed as a candidate drug for the topical, cream treatment of inflammatory skin diseases. As such, it affects T-cells through inhibition of T-cell activities including their infiltration processes, and it shows direct anti-inflammatory manifestation in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- WBI-1001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Oct 2008
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AD diagnosis (based on Hanifin's criteria) presenting a minimum of 1% and a maximum of 10% body surface area (BSA) excluding face, groin, scalp and genital areas.
- Disease severity index (EASI) of less than 12, Investigator's Global Assessment (IGA) of 2-3 at Day 0.
- In good general health and free of any condition that might impair evaluation of AD.
- Women of child bearing potential (WOCBP) had to have a negative a negative serum human-beta chorionic gonadotropin pregnancy test before randomization.
- WOCBP had to abstain from sex or they and their partners had to use adequate contraceptive precautions for the duration of the study.
- Willing and able to comply with the protocol and attend all study visits.
- Provide a written informed consent form prior to initiation of study procedures.
Who cannot join
- Had spontaneously improving or rapidly deteriorating AD.
- Had AD lesions on only hands and/or feet.
- Had skin diseases other than AD.
- Had active allergic contact dermatitis or other non-atopic forms of dermatitis.
- Had other concomitant medical condition that could put the patient at risk during the study.
- Had a history of neurological/psychiatric disorders that could interfere with the patient's participation.
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- Had systemic immunomodulatory therapies within 12 weeks prior to the baseline visit.
- Had prolonged exposure to natural or artificial ultraviolet radiation within 4 weeks of baseline visit.
- Had phototherapy (including laser), photo-chemotherapy or systemic AD therapy within 4 weeks prior to baseline visit.
- Had topical AD therapies in the areas to be treated within 2 weeks prior to the baseline visit.
- Had alcohol abuse in the last 2 years.
- Had allergic history to any non-medical ingredients of the study cream.
- Were treated with an investigational drug within 1 month of Day 0 or were currently participating in another trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blinded, Vehicle-Controlled Phase IIa Study to Evaluate Topically Applied WBI-1001 Cream in Patients With Atopic Dermatitis.
WBI-1001 is a synthetic,new, non-steroid, small molecule being developed as a candidate drug for the topical, cream treatment of inflammatory skin diseases. As such, it affects T-cells through inhibition of T-cell activities including their infiltration processes, and it shows direct anti-inflammatory manifestation in the mouse edema model. This was a 28 day study (plus one follow-up week) on patients with Atopic Dermatitis, and 36 patients were treated randomly, BID with either 0.5%, 1.0% or placebo. Blood samples were taken weekly for PK analysis.
Read the detailed description
A double-blind, single-centered, vehicle-controlled, randomized Phase IIa study of WBI-1001 on patients with mild to moderate Atopic Dermatitis (AD). All body areas were treatable except face, scalp, groin and genital areas. Cream applied BID between 6.00 and 10.00am and 7.00 and 10.00pm daily for 4 weeks. Blood draws for PK analysis were taken weekly at the study centre prior to the morning cream application. Patients returned to the study centre approximately one week later for a follow-up visit.
- Conditions
- Dermatitis, Atopic
- Being tested
- WBI-1001
- Keywords
- Non-steroid, Small molecule, Topical cream, Inflammatory disease, Skin
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBI-1001Drug
Doses of 0,0.5% and 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with one week follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 1 Placebo cream | Placebo comparator | 0% cream 12 patients Receives: Drug: WBI-1001 |
| 2. Cream | Active comparator | 0.5% WBI-1001 cream 12 patients Receives: Drug: WBI-1001 |
| 3. Cream | Active comparator | 1.0% WBI-1001 cream 12 patients Receives: Drug: WBI-1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate skin lesion condition as a measure of safety and tolerability of WBI-1001 treated AD patients.
Measured: 0, 7, 14, 21, 28 and 35 days
Secondary outcomes (2)
Assess systemic exposure of WBI-1001 treated AD patients by measuring plasma PK.
Measured: 0, 7, 14, 21 and 28 days
Explore efficacy of topically applied WBI-1001 cream in patients with AD.
Measured: 0, 7, 14, 21, 28 and 35 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startMar 2008
- Primary completionJun 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Welichem Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Bissonnette, MD, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837551
- Sponsor's protocol ID
- WBI-1001-201: Control # 119727
- Acronym
- WBI-1001-201
- Status last verified
- Feb 2009
- First submitted
- 3 Feb 2009
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Vehicle-Controlled Phase IIa Study to Evaluate Topically Applied WBI-1001 Cream in Patients With Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT00837551
- Acronym / sponsor ID
- WBI-1001-201 / WBI-1001-201: Control # 119727
- Conditions
- Dermatitis, Atopic
- Keywords
- Non-steroid, Small molecule, Topical cream, Inflammatory disease, Skin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Welichem Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Feb 2009 (estimated)
- 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.
WBI-1001 is a synthetic,new, non-steroid, small molecule being developed as a candidate drug for the topical, cream treatment of inflammatory skin diseases. As such, it affects T-cells through inhibition of T-cell activities including their infiltration processes, and it shows direct anti-inflammatory manifestation in the mouse edema model. This was a 28 day study (plus one follow-up week) on patients with Atopic Dermatitis, and 36 patients were treated randomly, BID with either 0.5%, 1.0% or placebo. Blood samples were taken weekly for PK analysis.
Detailed description
A double-blind, single-centered, vehicle-controlled, randomized Phase IIa study of WBI-1001 on patients with mild to moderate Atopic Dermatitis (AD). All body areas were treatable except face, scalp, groin and genital areas. Cream applied BID between 6.00 and 10.00am and 7.00 and 10.00pm daily for 4 weeks. Blood draws for PK analysis were taken weekly at the study centre prior to the morning cream application. Patients returned to the study centre approximately one week later for a follow-up visit.
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 |
|---|---|---|
| 1 Placebo cream | Placebo comparator | Drug: WBI-10010% cream 12 patients |
| 2. Cream | Active comparator | Drug: WBI-10010.5% WBI-1001 cream 12 patients |
| 3. Cream | Active comparator | Drug: WBI-10011.0% WBI-1001 cream 12 patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- AD diagnosis (based on Hanifin's criteria) presenting a minimum of 1% and a maximum of 10% body surface area (BSA) excluding face, groin, scalp and genital areas.
- Disease severity index (EASI) of less than 12, Investigator's Global Assessment (IGA) of 2-3 at Day 0.
- In good general health and free of any condition that might impair evaluation of AD.
- Women of child bearing potential (WOCBP) had to have a negative a negative serum human-beta chorionic gonadotropin pregnancy test before randomization.
- WOCBP had to abstain from sex or they and their partners had to use adequate contraceptive precautions for the duration of the study.
Key exclusion criteria (13 listed)
- Had spontaneously improving or rapidly deteriorating AD.
- Had AD lesions on only hands and/or feet.
- Had skin diseases other than AD.
- Had active allergic contact dermatitis or other non-atopic forms of dermatitis.
- Had other concomitant medical condition that could put the patient at risk during the study.
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 |
|---|---|---|
| WBI-1001Doses of 0,0.5% and 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with one week follow-up. | Drug | 1 Placebo cream, 2. Cream, 3. Cream |
Primary outcome
To evaluate skin lesion condition as a measure of safety and tolerability of WBI-1001 treated AD patients.
Time frame: 0, 7, 14, 21, 28 and 35 days
2 secondary outcomes
Assess systemic exposure of WBI-1001 treated AD patients by measuring plasma PK.
Time frame: 0, 7, 14, 21 and 28 days
Explore efficacy of topically applied WBI-1001 cream in patients with AD.
Time frame: 0, 7, 14, 21, 28 and 35 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 Feb 2009.
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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.
Robert Bissonnette, MD principal investigator
Innovaderm Research Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WBI-1001 in people with Dermatitis, Atopic, run by Welichem Biotech 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 7 inclusion and 13 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 Feb 2009. 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 combined 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.
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?
To evaluate skin lesion condition as a measure of safety and tolerability of WBI-1001 treated AD patients. (time frame: 0, 7, 14, 21, 28 and 35 days). 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 Feb 2009.