Pimecrolimus Cream 1% (Elidel®) and Medicated Device Cream (EletoneTM) in the Treatment and Maintenance of Atopic Dermatitis.

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emer, Jason, M.D.
• Collaborator: Ferndale Laboratories
• Treatments: Pimecrolimus; Tacrolimus

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.

• 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.