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

NCT01177566 | Completed Phase 4 DMC

• 1 other identifier: 08-1450
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Improvement in Physician Global Assessment (PGA)

  4 weeks

Secondary Outcomes (2)

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

  4 weeks

• Improvement in patient self-assessments

  4 weeks

Study Arms (2)

pimecrolimus (Elidel)

ACTIVE COMPARATOR

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

Drug: pimecrolimus

topical medical device cream (Eletone)

ACTIVE COMPARATOR

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

Device: topical medical device

Interventions

pimecrolimus DRUG

pimecrolimus 1% cream twice daily

pimecrolimus (Elidel)

topical medical device DEVICE

Eletone cream three times daily

topical medical device cream (Eletone)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emer, Jason, M.D.: lead
• Ferndale Laboratories: collaborator

Study Sites (1)

Mount Sinai School of Medicine Department of Dermatology Clinical Trials

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

pimecrolimus; Equipment and Supplies

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jason Emer, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 9, 2010
• Study Start: September 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 9, 2010

Record last verified: 2010-08

Locations

US (1)