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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01177566
Recruitment Status : Completed
First Posted : August 9, 2010
Last Update Posted : August 9, 2010
Ferndale Laboratories
Information provided by:
Emer, Jason, M.D.

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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

Primary Outcome Measures :
  1. Improvement in Physician Global Assessment (PGA) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Improvement of the signs of atopic dermatitis (erythema, population, infiltration, excoriation and lichenification) [ Time Frame: 4 weeks ]
  2. Improvement in patient self-assessments [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01177566

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United States, New York
Mount Sinai School of Medicine Department of Dermatology Clinical Trials
New York, New York, United States, 10029
Sponsors and Collaborators
Emer, Jason, M.D.
Ferndale Laboratories
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Principal Investigator: Jason Emer, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Jason Emer, MD, Mount Sinai School of Medicine, Department of Dermatology Clinical Trials Identifier: NCT01177566    
Other Study ID Numbers: 08-1450
First Posted: August 9, 2010    Key Record Dates
Last Update Posted: August 9, 2010
Last Verified: August 2010
Keywords provided by Emer, Jason, M.D.:
Atopic dermatitis
pimecrolimus cream 1%
medical device cream
topical calcineurin inhibitor
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action