None listed
Conditions
Interventions
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.
Sponsors
Corgentech Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed