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

Sponsor

Emer, Jason, M.D. (Other)

Overall Status

Completed

CT.gov ID

NCT01177566

Collaborator

Ferndale Laboratories (Other)

Enrollment

Location

Arms

5.9

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: pimecrolimus Device: topical medical device	Phase 4

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 Eletone™ 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: pimecrolimus (Elidel) pimecrolimus twice daily to a chosen target lesion on one side of body	Drug: pimecrolimus pimecrolimus 1% cream twice daily
Active Comparator: topical medical device cream (Eletone) topical medical device cream three times daily to a chosen target lesion on one side of the body	Device: topical medical device Eletone cream three times daily

Arm

Intervention/Treatment

Active Comparator: pimecrolimus (Elidel)

pimecrolimus twice daily to a chosen target lesion on one side of body

Drug: pimecrolimus

pimecrolimus 1% cream twice daily

Active Comparator: topical medical device cream (Eletone)

topical medical device cream three times daily to a chosen target lesion on one side of the body

Device: topical medical device

Eletone cream three times daily

Outcome Measures

Primary Outcome Measures

Improvement in Physician Global Assessment (PGA) [4 weeks]

Secondary Outcome Measures

Improvement of the signs of atopic dermatitis (erythema, population, infiltration, excoriation and lichenification) [4 weeks]
Improvement in patient self-assessments [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.