Pimecrolimus Cream 1% (Elidel�) and Medicated Device Cream (EletoneTM) in the Treatment and Maintenance of Atopic Dermatitis.
Information source: Emer, Jason, M.D.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis
Intervention: pimecrolimus (Drug); topical medical device (Device)
Phase: Phase 4
Status: Completed
Sponsored by: Emer, Jason, M.D. Official(s) and/or principal investigator(s): Jason Emer, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai
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.
Clinical Details
Official title: Pimecrolimus Cream 1% (Elidel®) and Medicated Device Cream (EletoneTM) in the Treatment and Maintenance of Atopic Dermatitis.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Improvement in Physician Global Assessment (PGA)
Secondary outcome: Improvement of the signs of atopic dermatitis (erythema, population, infiltration, excoriation and lichenification)Improvement in patient self-assessments
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 corticosteroids, it is not optimal to expose a patient to the long term use of
topical corticosteroids. Side effects of long term steroid use include skin atrophy,
striae, tachyphylaxis, adrenal suppression, bacterial infections, and contact allergies to
name a few. Elidel® (pimecrolimus) cream 1% and Eletone™ cream are both alternative topical
therapies FDA approved for use in patients with atopic dermatitis. Each has an independent
mechanism of action that has been shown in clinical trials to deliver itch relief, reduce
eczema flares and maintain remission, thus providing an adequate treatment option when
topical steroids are not preferred or contraindicated. Thus far, no study has evaluated the
efficacy of these two products head-to-head. This is an investigator-blinded, bilateral
comparison study in 20 subjects with atopic dermatitis. It is designed to assess and
compare the efficacy Elidel® (pimecrolimus) cream 1% and Eletone™ cream in patients 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
Eletoneâ„¢ 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 side the subject applies
each medication. Patients will be clinically evaluated every two weeks by the investigator
on a Physician Global Assessment (PGA) scale. Part of this clinical study consists of the
use of patient and self-assessment questionnaires and the use of non-identifying digital
photography of target lesions.
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Mount Sinai School of Medicine Department of Dermatology Clinical Trials, New York, New York 10029, United States
Additional Information
Starting date: September 2009
Last updated: August 5, 2010
|