Atopic Dermatitis Clinical Trial
Official title:
Pimecrolimus Cream 1% (Elidel®) and Medicated Device Cream (EletoneTM) in the Treatment and Maintenance of Atopic Dermatitis.
Verified date | August 2010 |
Source | Emer, Jason, M.D. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess a bilateral comparison between pimecrolimus cream 1% (Elidel®) and a medical device cream (EletoneTM) in the treatment and management of atopic dermatitis. Study subjects will apply pimecrolimus twice daily for four weeks on a target area located on one side of the body, and apply the medical device cream three times daily for four weeks on the opposite side of the body at a target lesion symmetric to the other.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years and older |
Eligibility |
Inclusion Criteria: - Males and females = 2 years old. - Subjects must be in good general health as confirmed by medical history and physical examination. - Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine). NOTE: Post-menopausal (amenorrheic for at least one year) and surgically sterile (tubal ligation and/or hysterectomy) are considered to be of non child-bearing potential. - Clear diagnosis of atopic dermatitis for at least one year. - Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity) for each selected target lesion - Disease must be stable or slowly worsening for more than one week prior to entering the study. - Subjects must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration. Exclusion Criteria: - Females who are pregnant, attempting to conceive, or breastfeeding. - Subjects with known hypersensitivity to study drug. - Subjects with overt signs of skin atrophy, telangiectasias and/or striae in the target area. - Subjects with a current active skin malignancy or infection. - Subjects requiring the use of medications known to alter the course of atopic dermatitis during the study treatment. - Subjects who have received systemic antibiotics within 2 weeks. - Subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study. - Subjects who have received topical corticosteroids or other topical therapies (tar, calcineurin inhibitors) for atopic dermatitis within 7 days of entering the study. - Subjects using phototherapy (UVB, PUVA) within 28 days of entering the study. - Subjects who are currently participating in or, with in the previous 28 days, have participated in another study for the treatment of atopic dermatitis. - Subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject. |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai School of Medicine Department of Dermatology Clinical Trials | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Emer, Jason, M.D. | Ferndale Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in Physician Global Assessment (PGA) | 4 weeks | ||
Secondary | Improvement of the signs of atopic dermatitis (erythema, population, infiltration, excoriation and lichenification) | 4 weeks | ||
Secondary | Improvement in patient self-assessments | 4 weeks |
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