Status:
COMPLETED
Pimecrolimus Cream 1% (Elidel®) and Medicated Device Cream (EletoneTM) in the Treatment and Maintenance of Atopic Dermatitis.
Lead Sponsor:
Emer, Jason, M.D.
Collaborating Sponsors:
Ferndale Laboratories
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
Atopic dermatitis (AD) is a common and chronic inflammatory skin disease that affects a large part of the population. Although atopic dermatitis responds well to twice daily mid-strength corticosteroi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01177566
Start Date
September 1 2009
End Date
March 1 2010
Last Update
August 9 2010
Active Locations (1)
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1
Mount Sinai School of Medicine Department of Dermatology Clinical Trials
New York, New York, United States, 10029