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

February 3, 2009
February 3, 2009
March 2008
June 2008   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase IIa Study of WBI-1001 Cream for Atopic Dermatitis
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dermatitis, Atopic
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.
  • Placebo Comparator: 1 Placebo cream
    0% cream 12 patients
    Intervention: Drug: WBI-1001
  • Active Comparator: 2. Cream
    0.5% WBI-1001 cream 12 patients
    Intervention: Drug: WBI-1001
  • Active Comparator: 3. Cream
    1.0% WBI-1001 cream 12 patients
    Intervention: Drug: WBI-1001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00837551
WBI-1001-201: Control # 119727
Yes
Robert Bissonnette, Innovaderm Reseaerch Inc.
Welichem Biotech Inc.
Not Provided
Principal Investigator: Robert Bissonnette, MD Innovaderm Research Inc.
Welichem Biotech Inc.
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP