Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis
A Phase 1/2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety of Repeated Topical Application of Three Concentrations of NF-kappaB Decoy in Adults With Mild-to-Moderate Atopic Dermatitis
1 other identifier
interventional
75
1 country
9
Brief Summary
The purpose of this study is to determine whether this topical NF-kappaB Decoy candidate is safe in persons with atopic dermatitis. Preliminary evidence of efficacy (whether it is working) will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2005
Shorter than P25 for phase_1
9 active sites
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, 2005
CompletedFirst Submitted
Initial submission to the registry
July 28, 2005
CompletedFirst Posted
Study publicly available on registry
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedNovember 19, 2008
November 1, 2008
July 28, 2005
November 18, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability of twice-daily topical application of three concentrations of NF-kappaB Decoy in adult subjects with mild-to-moderate atopic dermatitis
Secondary Outcomes (2)
To make a preliminary evaluation of the efficacy of the topical NF-kappaB Decoy in the treatment of mild-to-moderate atopic dermatitis in adult subjects
To evaluate the systemic pharmacokinetic (PK) profile of NF-kappaB Decoy
Interventions
Eligibility Criteria
You may qualify if:
- Are 18 through 65 years of age and sign an informed consent
- Have been given a diagnosis of mild to moderate atopic dermatitis as defined by: \*Pruritus; \*Eczematous dermatitis (acute, subacute, chronic) involving at least current or prior flexural lesions with chronic or relapsing course; \*Early age of onset (prior to 10 years of age, by history); \*Personal or family history of atopy
- If receiving antihistamines, are on a stabilized dose, and expect to maintain this dose throughout the study
- Are females or males of reproductive potential who are compliant in using adequate birth control or are females or males not of reproductive potential
You may not qualify if:
- Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
- Have immunocompromised status (such as known human immunodeficiency virus infection)
- Have any clinically significant abnormal clinical laboratory test results at Screening
- Have a history of malignancy not in remission for at least 5 years excluding basal cell carcinoma and nonperiorificial squamous cell carcinoma of the skin
- Have an active intercurrent infection
- Have applied any topical medication (including corticosteroid, calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment within 1 week of the Day 1 visit; have used any systemic antibiotic within 1 week prior to the Day 1 visit; have used any systemic treatment for atopic dermatitis (including systemic corticosteroids, nonsteroidal immunosuppressants, or treatment with light) within 4 weeks prior to the Day 1 visit; have used an investigational drug for any reason within 4 weeks of the Day 1 visit; have used intranasal and/or inhaled corticosteroids at doses \> 2 mg prednisone or equivalent per day within 4 weeks of the Day 1 visit; or have used immunosuppressive or immunomodulating drugs such as etanercept, alefacept, or infliximab within 16 weeks prior to Day 1
- Have a history of hypersensitivity or allergic reactions to parabens or any other ingredient in the vehicle formulation
- If female, are pregnant or lactating, or intend to become pregnant during the study period
- If male, have a female partner who is pregnant or lactating, or intends to become pregnant during the study period
- Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anesiva, Inc.lead
Study Sites (9)
University of Miami Skin Research
Miami, Florida, 33136, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Helendale Dermatology & Medical Spa, LLP
Rochester, New York, 14609, United States
Oregon Health & Science University, Department of Dermatology
Portland, Oregon, 97201, United States
Derm Research, Inc.
Austin, Texas, 78759, United States
Center for Clinical Studies
Houston, Texas, 77030, United States
Center for Clinical Studies
South Houston, Texas, 77058, United States
Madison Skin & Research, Inc.
Madison, Wisconsin, 53719, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andria Langenberg, MD
Anesiva, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 28, 2005
First Posted
August 1, 2005
Study Start
March 1, 2005
Study Completion
November 1, 2005
Last Updated
November 19, 2008
Record last verified: 2008-11