Bilateral Comparison Study of Elidel 1% and Hylatopic Plus Emollient Foam for the Treatment of Subjects With Atopic Dermatitis

Launched by FRANKEL, AMYLYNNE, M.D. · Sep 14, 2010

Keywords

ClinConnect 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™ Plus Emollient Foam™ in subjects with atopic dermatitis. Subjects will apply Elidel® (pimecrolimus) cream 1% twice daily for four weeks on a chosen target eczematous area located on one side of the body and then apply Hylatopic™ Plus Emollient Foam™ three times daily on a symmetrical target eczematous area on the opposite side of the body. A randomized list will be created to determine which sid...

Gender

ALL

Eligibility criteria

• 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.
• • 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 Criteria:
• • 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.