Phase IIa Study of WBI-1001 Cream for Atopic Dermatitis

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Welichem Biotech Inc.

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.