NCT00837551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
Last Updated

February 5, 2009

Status Verified

February 1, 2009

Enrollment Period

3 months

First QC Date

February 3, 2009

Last Update Submit

February 3, 2009

Conditions

Dermatitis, Atopic

Keywords

Non-steroidSmall moleculeTopical creamInflammatory diseaseSkin

Outcome Measures

Primary Outcomes (1)

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

    0, 7, 14, 21, 28 and 35 days

Secondary Outcomes (2)

  • Assess systemic exposure of WBI-1001 treated AD patients by measuring plasma PK.

    0, 7, 14, 21 and 28 days

  • Explore efficacy of topically applied WBI-1001 cream in patients with AD.

    0, 7, 14, 21, 28 and 35 days.

Study Arms (3)

1 Placebo cream

PLACEBO COMPARATOR

0% cream 12 patients

Drug: WBI-1001

2. Cream

ACTIVE COMPARATOR

0.5% WBI-1001 cream 12 patients

Drug: WBI-1001

3. Cream

ACTIVE COMPARATOR

1.0% WBI-1001 cream 12 patients

Drug: WBI-1001

Interventions

WBI-1001DRUG

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.

1 Placebo cream2. Cream3. Cream

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovaderm Research Inc.,

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

tapinarof

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Robert Bissonnette, MD

    Innovaderm Research Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 5, 2009

Study Start

March 1, 2008

Primary Completion

June 1, 2008

Study Completion

October 1, 2008

Last Updated

February 5, 2009

Record last verified: 2009-02

Locations

CA(1)