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

This study has been completed.
Sponsor:
Information provided by:
Welichem Biotech Inc.
ClinicalTrials.gov Identifier:
NCT00837551
First received: February 3, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Dermatitis, Atopic
Drug: WBI-1001
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Vehicle-Controlled Phase IIa Study to Evaluate Topically Applied WBI-1001 Cream in Patients With Atopic Dermatitis.

Further study details as provided by Welichem Biotech Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess systemic exposure of WBI-1001 treated AD patients by measuring plasma PK. [ Time Frame: 0, 7, 14, 21 and 28 days ] [ Designated as safety issue: Yes ]
  • Explore efficacy of topically applied WBI-1001 cream in patients with AD. [ Time Frame: 0, 7, 14, 21, 28 and 35 days. ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: March 2008
Study Completion Date: October 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Placebo cream
0% cream 12 patients
Drug: WBI-1001
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.
Active Comparator: 2. Cream
0.5% WBI-1001 cream 12 patients
Drug: WBI-1001
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.
Active Comparator: 3. Cream
1.0% WBI-1001 cream 12 patients
Drug: WBI-1001
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837551

Locations
Canada, Quebec
Innovaderm Research Inc.,
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Welichem Biotech Inc.
Investigators
Principal Investigator: Robert Bissonnette, MD Innovaderm Research Inc.
  More Information

No publications provided

Responsible Party: Robert Bissonnette, Innovaderm Reseaerch Inc.
ClinicalTrials.gov Identifier: NCT00837551     History of Changes
Other Study ID Numbers: WBI-1001-201: Control # 119727
Study First Received: February 3, 2009
Last Updated: February 3, 2009
Health Authority: Canada: Health Canada

Keywords provided by Welichem Biotech Inc.:
Non-steroid
Small molecule
Topical cream
Inflammatory disease
Skin

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014