Status:
COMPLETED
Phase IIa Study of WBI-1001 Cream for Atopic Dermatitis
Lead Sponsor:
Welichem Biotech Inc.
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 inhibit...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00837551
Start Date
March 1 2008
End Date
October 1 2008
Last Update
February 5 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Innovaderm Research Inc.,
Montreal, Quebec, Canada, H2K 4L5