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

This study has been completed.
Sponsor:
Collaborator:
Ferndale Laboratories
Information provided by:
Emer, Jason, M.D.
ClinicalTrials.gov Identifier:
NCT01177566
First received: August 4, 2010
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Atopic Dermatitis
Drug: pimecrolimus
Device: topical medical device
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Pimecrolimus Cream 1% (Elidel®) and Medicated Device Cream (EletoneTM) in the Treatment and Maintenance of Atopic Dermatitis.

Resource links provided by NLM:


Further study details as provided by Emer, Jason, M.D.:

Primary Outcome Measures:
  • Improvement in Physician Global Assessment (PGA) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of the signs of atopic dermatitis (erythema, population, infiltration, excoriation and lichenification) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Improvement in patient self-assessments [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177566

Locations
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
Investigators
Principal Investigator: Jason Emer, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Jason Emer, MD, Mount Sinai School of Medicine, Department of Dermatology Clinical Trials
ClinicalTrials.gov Identifier: NCT01177566     History of Changes
Other Study ID Numbers: 08-1450
Study First Received: August 4, 2010
Last Updated: August 5, 2010
Health Authority: United States: Food and Drug Administration
United States: Program for the Protection of Human Subjects

Keywords provided by Emer, Jason, M.D.:
Atopic dermatitis
Elidel
pimecrolimus cream 1%
Eletone
medical device cream
topical calcineurin inhibitor

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014