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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

pimecrolimus

topical medical device

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, Elidel, pimecrolimus cream 1%, Eletone, medical device cream, topical calcineurin inhibitor

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Mount Sinai School of Medicine Department of Dermatology Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

pimecrolimus (Elidel)

topical medical device cream (Eletone)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement in Physician Global Assessment (PGA)

Secondary Outcome Measures

Improvement of the signs of atopic dermatitis (erythema, population, infiltration, excoriation and lichenification)

Improvement in patient self-assessments

Full Information

NCT ID

NCT01177566

First Posted

August 4, 2010

Last Updated

August 5, 2010

Sponsor

Emer, Jason, M.D.

Collaborators

Ferndale Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT01177566

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Emer, Jason, M.D.

Collaborators

Ferndale Laboratories

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Atopic dermatitis, Elidel, pimecrolimus cream 1%, Eletone, medical device cream, topical calcineurin inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pimecrolimus (Elidel)

Arm Type

Active Comparator

Arm Description

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

Arm Title

topical medical device cream (Eletone)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

pimecrolimus

Intervention Description

pimecrolimus 1% cream twice daily

Intervention Type

Device

Intervention Name(s)

topical medical device

Intervention Description

Eletone cream three times daily

Primary Outcome Measure Information:

Title

Improvement in Physician Global Assessment (PGA)

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Improvement of the signs of atopic dermatitis (erythema, population, infiltration, excoriation and lichenification)

Time Frame

4 weeks

Title

Improvement in patient self-assessments

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jason Emer, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai School of Medicine Department of Dermatology Clinical Trials

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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