Atopic DermatitisPhase 1/2NCT00125333
Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis
A Phase 1/2 study testing NF-kappaB Decoy in people with Atopic Dermatitis, run by Anesiva, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- NF-kappaB Decoy
- How many people
- 75 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2005to Nov 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Derm Research, Inc.
Austin, Texas, 78759
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Center for Clinical Studies
Houston, Texas, 77030
Madison Skin & Research, Inc.
Madison, Wisconsin, 53719
University of Miami Skin Research
Miami, Florida, 33136
Mount Sinai School of Medicine
New York, New York, 10029
Oregon Health & Science University, Department of Dermatology
Portland, Oregon, 97201
Helendale Dermatology & Medical Spa, LLP
Rochester, New York, 14609
Center for Clinical Studies
South Houston, Texas, 77058
About this study
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
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- NF-kappaB Decoy
- Keywords
- atopic dermatitis, eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NF-kappaB DecoyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startMar 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Anesiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andria Langenberg, MD, Study director, Anesiva, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125333
- Sponsor's protocol ID
- 110-01P
- Status last verified
- Nov 2008
- First submitted
- 28 Jul 2005
- Last updated
- 19 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00125333
- Acronym / sponsor ID
- 110-01P
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, eczema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Anesiva, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Nov 2005
- First posted
- 1 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NF-kappaB Decoy | Drug | – |
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andria Langenberg, MD study director
Anesiva, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NF-kappaB Decoy in people with Atopic Dermatitis, run by Anesiva, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2008.