Combination Therapy for Atopic Dermatitis

Last updated: July 23, 2010
Sponsor: Children's Hospital of Philadelphia
Overall Status: Completed

Phase

4

Condition

Eczema (Atopic Dermatitis)

Allergy

Atopic Dermatitis

Treatment

N/A

Clinical Study ID

NCT00119158
2004-10-3975
  • Ages 2-65
  • All Genders

Study Summary

Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin inhibitors.

Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance.

The hypothesis of this trial is that the combination of the two agents will lead to faster clearance than the single agent of topical corticosteroids.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 2 to 65 years

  • Clinical diagnosis of (Atopic Dermatitis) AD according to the American Academy ofDermatology (AAD) Consensus Conference (2001)

  • At least two lesions of AD on symmetrical part of the body (same location for eachside of the body), of severe intensity (m-EASI is at least 7 on each site, witherythema of at least 3 (severe) and papulation/infiltration of at least 3 (severe))and similar severity (m-EASI does not differ from more than 2 points on both sides)

  • Signed written informed consent

  • Willingness and ability to comply with the study requirements

  • Female is able to enter and participate in this study if she is of:

  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant)or

  • Childbearing potential, has a negative pregnancy test (urine) at the screen visitand agrees to an adequate method of birth control throughout the study (whichmay, at the investigator's discretion, include abstinence)

Exclusion

Exclusion Criteria:

  • History of immune deficiencies or history of malignant disease

  • Patients with moderate to severe lichenification at the target areas (i.e. score 2 or

  • Active cutaneous bacterial, viral or fungal infections in target areas

  • History of other skin disorders, including Netherton syndrome, that could interferewith the evaluations

  • Use of any topical treatment known or suspected to have an effect on atopic dermatitiswithin one week prior to the screen visit (except for calcineurin inhibitors, forwhich the washout is 2 weeks)

  • Use of any systemic treatment (including phototherapy) known or suspected to have aneffect on AD within four weeks prior to the screen visit [(patients on a stable andlow dose of inhaled steroids, on a stable dose of anti histamines, on stable dose ofleukotriene antagonists, or receiving occasional short-acting b2-agonists for thetreatment of asthma and topical corticosteroids (nasal spray) for the treatment ofallergic rhinitis may participate). High-dose inhaled corticosteroids (> 440 mcg offluticasone a day) and anti-IgE products are not permitted].

  • Known sensitivity to pimecrolimus or vehicle (placebo) or fluticasone propionate creamor any of their ingredients

  • Patients with severe medical condition(s) that in the view of the investigatorprohibits participation in the study

  • Use of any other investigational agent in the last 30 days

Study Design

Total Participants: 90
Study Start date:
October 01, 2004
Estimated Completion Date:
June 30, 2005

Study Description

This trial is a double-blind controlled trial of fluticasone cream daily and pimecrolimus cream BID versus fluticasone cream daily and placebo cream BID for the treatment of acute flares of atopic dermatitis.

While pimecrolimus cream 1% has been proven to be effective in mild and moderate Atopic dermatitis (AD), there is a need for a fast control of severe skin lesions. On the other hand, reducing the duration of the topical corticosteroid treatment is a reasonable approach to minimize the occurrence of adverse effects.

Because pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance.

In vitro data have demonstrated that a combination of steroids and tacrolimus has synergistic effects on in vitro human lymphocyte proliferation. In addition, it has previously been reported, in a pilot investigation in two subjects, that a combination regimen of pimecrolimus 1% twice a day and fluticasone propionate cream 0.05% once daily was superior to fluticasone propionate cream 0.05% once daily in the acute treatment of atopic dermatitis (AD).

This study is conducted to validate these findings in a larger number of patients.

Connect with a study center

  • National Jewish Research Medical Center

    Denver, Colorado 80206
    United States

    Site Not Available

  • Northwestern University School of Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Texas at Houston Medical School

    Houston, Texas 77030
    United States

    Site Not Available

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