Status:
COMPLETED
Bilateral Comparison Study of Elidel 1% and Hylatopic Plus Emollient Foam for the Treatment of Subjects With Atopic Dermatitis
Lead Sponsor:
Frankel, Amylynne, M.D.
Collaborating Sponsors:
Onset Therapeutics, Inc
Conditions:
Eczema
Atopic Dermatitis
Eligibility:
All Genders
2+ years
Phase:
PHASE4
Brief Summary
This is an investigator-blinded, bilateral comparison study in 30 subjects with atopic dermatitis. It is designed to assess and compare the efficacy of Elidel® (pimecrolimus) cream 1% and Hylatopic™ P...
Detailed Description
This is an investigator-blinded, bilateral comparison study in 30 subjects with atopic dermatitis. It is designed to assess and compare the efficacy of Elidel® (pimecrolimus) cream 1% and Hylatopic™ P...
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.
- Diagnosis of atopic dermatitis for at least one year with symptoms on arms, trunk, and/or legs.
- Subject must have a static Investigator's Global Assessment (IGA) of at least 2 or 3 (mild-moderate severity) for each selected target lesion
- Disease must be stable or slowly worsening for more than one week prior to the Screening Visit, as reported by the subject.
- Subjects or their guardians 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 either study drug.
- Subjects with AD on \>30% body surface area
- 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 the Screening Visit.
- Subjects who have received topical corticosteroids or other topical therapies (tar, calcineurin inhibitors) for atopic dermatitis within 7 days of the Screening Visit.
- Subjects using phototherapy (UVB, PUVA) within 28 days of the Screening Visit.
- 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 pose 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 :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01202149
Start Date
March 1 2010
End Date
November 1 2010
Last Update
April 15 2011
Active Locations (1)
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1
Mount Sinai Faculty Practice Associates
New York, New York, United States, 10029