Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000403639
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
14/09/2005
Date last updated
14/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase 1/2 Multicenter, Randomized, Placebo-Controlled Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Two Regimens of a Candidate Topical NF kappaB Decoy in the Treatment of Adults with Mild to Moderate Atopic Dermatitis
Scientific title
A Phase 1/2 Multicenter, Randomized, Placebo-Controlled Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Two Regimens of a Candidate Topical NF kappaB Decoy in the Treatment of Adults with Mild to Moderate Atopic Dermatitis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic dermatitis 509 0
Condition category
Condition code
Skin 587 587 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible subjects will be randomized (flipping a coin) to either active treatment or placebo (placebo means the vehicle gel without the active ingredient), which will be applied per protocol either once or twice daily for a total of 4 weeks. A 2 week follow-up period will follow the treatment period.
Intervention code [1] 404 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 681 0
To evaluate the safety of once-daily (qd) and twice-daily (bid) topical application of NF kappaB Decoy in adult patients with mild to moderate atopic dermatitis
Timepoint [1] 681 0
Evaluated at each study visit.
Primary outcome [2] 682 0
To evaluate the tolerability of once-daily (qd) and twice-daily (bid) topical application of NF kappaB Decoy in adult patients with mild to moderate atopic dermatitis
Timepoint [2] 682 0
Evaluated at each study visit.
Secondary outcome [1] 1395 0
To maTo make a preliminary evaluation of the efficacy of qd and bid topical application of NF kappaB Decoy in adult patients with mild to moderate atopic dermatitis.ke a preliminary evaluation of the efficacy of qd and bid topical application of NF kappaB Decoy in adult patients with mild to moderate atopic dermatitis.
Timepoint [1] 1395 0
Evaluated at each study visit.

Eligibility
Key inclusion criteria
Subjects in good health, who: 1. Sign an informed consent; 2. Have been given a diagnosis of 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; 3. If receiving antihistamines, are on a stabilized dose, and expect to maintain this dose throughout the study; 4. Are females or males of reproductive potential who are compliant in using adequate birth control or are females or males not of reproductive potential.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have concomitant dermatologic or medical condition(s) which may interfere with the investigatorâ¿¿s ability to evaluate the subjectâ¿¿s response to the study drug; 2. Have immunocompromised status (such as known human immunodeficiency virus infection); 3. Have an active intercurrent infection, a clinically significant clinical laboratory test abnormality, or any poorly controlled medical condition; 4. 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 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; 5. Have a history of hypersensitivity or allergic reactions to parabens or any other ingredient in the vehicle formulation; 6. If female, are pregnant or lactating, or intend to become pregnant during the study period; 7. If male, have a female partner who is pregnant or lactating, or who intends to become pregnant during the study period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation with numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization schedule was generated using SAS procedure PROC PLAN (SAS Version 8.2). To keep the balance of the treatment allocation, randomization list was generated using blocks to allocate active QD, active BID, placebo QD, and placebo BID groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 641 0
Commercial sector/Industry
Name [1] 641 0
Corgentech Inc.
Country [1] 641 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Corgentech Inc.
Address
Country
United States of America
Secondary sponsor category [1] 538 0
None
Name [1] 538 0
None
Address [1] 538 0
Country [1] 538 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36266 0
Address 36266 0
Country 36266 0
Phone 36266 0
Fax 36266 0
Email 36266 0
Contact person for public queries
Name 9593 0
Julie Pompili
Address 9593 0
Level 10
606 St Kilda Road
Melbourne VIC 3004
Country 9593 0
Australia
Phone 9593 0
+61 3 95196852
Fax 9593 0
+61 3 95196888
Email 9593 0
julie.pompili@quintiles.com
Contact person for scientific queries
Name 521 0
Julie Pompili
Address 521 0
Level 10
606 St Kilda Road
Melbourne VIC 3004
Country 521 0
Australia
Phone 521 0
+61 3 95196852
Fax 521 0
+61 3 95196888
Email 521 0
julie.pompili@quintiles.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.