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Phase IIa Study of WBI-1001 Cream for Atopic Dermatitis (WBI-1001-201)

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
WBI-1001
Sponsored by
Welichem Biotech Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Non-steroid, Small molecule, Topical cream, Inflammatory disease, Skin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Innovaderm Research Inc.,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

1 Placebo cream

2. Cream

3. Cream

Arm Description

0% cream 12 patients

0.5% WBI-1001 cream 12 patients

1.0% WBI-1001 cream 12 patients

Outcomes

Primary Outcome Measures

To evaluate skin lesion condition as a measure of safety and tolerability of WBI-1001 treated AD patients.

Secondary Outcome Measures

Assess systemic exposure of WBI-1001 treated AD patients by measuring plasma PK.
Explore efficacy of topically applied WBI-1001 cream in patients with AD.

Full Information

First Posted
February 3, 2009
Last Updated
February 3, 2009
Sponsor
Welichem Biotech Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00837551
Brief Title
Phase IIa Study of WBI-1001 Cream for Atopic Dermatitis
Acronym
WBI-1001-201
Official Title
A Randomized, Double-Blinded, Vehicle-Controlled Phase IIa Study to Evaluate Topically Applied WBI-1001 Cream in Patients With Atopic Dermatitis.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Welichem Biotech Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Non-steroid, Small molecule, Topical cream, Inflammatory disease, Skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Placebo cream
Arm Type
Placebo Comparator
Arm Description
0% cream 12 patients
Arm Title
2. Cream
Arm Type
Active Comparator
Arm Description
0.5% WBI-1001 cream 12 patients
Arm Title
3. Cream
Arm Type
Active Comparator
Arm Description
1.0% WBI-1001 cream 12 patients
Intervention Type
Drug
Intervention Name(s)
WBI-1001
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Assess systemic exposure of WBI-1001 treated AD patients by measuring plasma PK.
Time Frame
0, 7, 14, 21 and 28 days
Title
Explore efficacy of topically applied WBI-1001 cream in patients with AD.
Time Frame
0, 7, 14, 21, 28 and 35 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bissonnette, MD
Organizational Affiliation
Innovaderm Research Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovaderm Research Inc.,
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Phase IIa Study of WBI-1001 Cream for Atopic Dermatitis

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