Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis
Information source: Anesiva, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis
Intervention: NF-kappaB Decoy (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Anesiva, Inc. Official(s) and/or principal investigator(s): Andria Langenberg, MD, Study Director, Affiliation: Anesiva, Inc.
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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 outcome: 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 subjectsTo evaluate the systemic pharmacokinetic (PK) profile of NF-kappaB Decoy
Detailed description:
This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study
to evaluate the safety of repeated application of three concentrations of NF-kappaB Decoy in
approximately 75 subjects with mild-to-moderate atopic dermatitis. The face, hands, feet,
scalp, or groin may NOT be treated.
Other treatment agents are currently available for atopic dermatitis but present significant
potential side effects (topical steroids) or are potent immunosuppressives (topical
calcineurin inhibitors) with pending longer-term safety data.
NF-kappaB Decoy is a double-stranded deoxyribonucleic acid (DNA) oligodeoxynucleotide that
mimics the NF-kappaB binding sequence on the chromosomal DNA, thereby inhibiting the
production of the inflammatory response triggered by NF-kappaB. This mechanism of action
presents a unique treatment modality.
A comprehensive series of nonclinical data have produced promising results.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
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
Additional Information
Starting date: March 2005
Last updated: November 18, 2008
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