Combination Therapy for Atopic Dermatitis

NCT00119158 | Completed Phase 4 Results

• 1 other identifier: 2004-10-3975
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Atopic Dermatitis

Keywords

THerapy for acute moderate to severe flares

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the m-EASI (Eczema Area Severity Index) Score.

  Eczema Area severity index (EASI) is a composition of scores based on area of eczema involved, (0 = mild to 3 = severe) for four separate Atopic Dermatitis (AD) symptoms: erythema,infiltration ⁄population, excoriation and ichenification. Total score 0-12

  up to 15 days

Secondary Outcomes (6)

• The Time to Clearance of the Disease

  assessed up to 30 days following drug application

• The Time to the First Day When m-EASI is Scored by the Investigator as 2 or Less

  up to one week

• The Percentage of Target Areas Reaching a l-IGA (Localized Investigator Global Assessment (l-IGA) or 0 or 1)

  up to 15 days

• The Percentage of Target Areas Improved (i.e., Decrease in Localized Investigator Global Assessmet (l-IGA) Score From Baseline)

  up to 15 days

• The Percentage of Target Areas Reaching a m-EASI (Modifed-Eczema Area Severity Index) Score of 2 or Less

  up to one week

Study Arms (2)

placebo

PLACEBO COMPARATOR

Placebo cream

Drug: pimecrolimus

pimecrolimus cream

ACTIVE COMPARATOR

Drug: Combination of pimecrolimus and fluticasone; Drug: pimecrolimus

Interventions

Combination of pimecrolimus and fluticasone DRUG

Pimecrolimus cream twice a day and fluticasone cream once a day

Also known as: Pimecrolimus cream, fluticasone

pimecrolimus cream

pimecrolimus DRUG

apply daily with fluticasone cream for flares

pimecrolimus cream; placebo

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 2 to 65 years
• Clinical diagnosis of (Atopic Dermatitis) AD according to the American Academy of Dermatology (AAD) Consensus Conference (2001)
• At least two lesions of AD on symmetrical part of the body (same location for each side of the body), of severe intensity (m-EASI is at least 7 on each site, with erythema 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 visit and agrees to an adequate method of birth control throughout the study (which may, at the investigator's discretion, include abstinence)

You may not qualify if:

• History of immune deficiencies or history of malignant disease
• Patients with moderate to severe lichenification at the target areas (i.e. score 2 or 3)
• Active cutaneous bacterial, viral or fungal infections in target areas
• History of other skin disorders, including Netherton syndrome, that could interfere with the evaluations
• Use of any topical treatment known or suspected to have an effect on atopic dermatitis within one week prior to the screen visit (except for calcineurin inhibitors, for which the washout is 2 weeks)
• Use of any systemic treatment (including phototherapy) known or suspected to have an effect on AD within four weeks prior to the screen visit \[(patients on a stable and low dose of inhaled steroids, on a stable dose of anti histamines, on stable dose of leukotriene antagonists, or receiving occasional short-acting b2-agonists for the treatment of asthma and topical corticosteroids (nasal spray) for the treatment of allergic rhinitis may participate). High-dose inhaled corticosteroids (\> 440 mcg of fluticasone a day) and anti-IgE products are not permitted\].
• Known sensitivity to pimecrolimus or vehicle (placebo) or fluticasone propionate cream or any of their ingredients
• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
• Use of any other investigational agent in the last 30 days

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (3)

National Jewish Research Medical Center

Denver, Colorado, 80206, United States

Location

Northwestern University School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Texas at Houston Medical School

Houston, Texas, 77030, United States

Location

Related Publications (7)

• Spergel J, Hultsch T. Pimecrolimus cream 1% and fluticasone propionate cream 0.05% versus fluticasone propionate cream 0.05% for the treatment of flares of atopic dermatitis. 28th Annual Hawaii Dermatology Seminar, 2004

  BACKGROUND

• Leung DY, Boguniewicz M, Howell MD, Nomura I, Hamid QA. New insights into atopic dermatitis. J Clin Invest. 2004 Mar;113(5):651-7. doi: 10.1172/JCI21060.

  PMID: 14991059 BACKGROUND

• Grassberger M, Baumruker T, Enz A, Hiestand P, Hultsch T, Kalthoff F, Schuler W, Schulz M, Werner FJ, Winiski A, Wolff B, Zenke G. A novel anti-inflammatory drug, SDZ ASM 981, for the treatment of skin diseases: in vitro pharmacology. Br J Dermatol. 1999 Aug;141(2):264-73. doi: 10.1046/j.1365-2133.1999.02974.x.

  PMID: 10468798 BACKGROUND

• Eichenfield LF, Lucky AW, Boguniewicz M, Langley RG, Cherill R, Marshall K. 1% pimecrolimus cream for atopic dermatitis. Arch Dermatol. 2003 Oct;139(10):1369-70; author reply 1370-1. doi: 10.1001/archderm.139.10.1369. No abstract available.

  PMID: 14568846 BACKGROUND

• Wahn U, Bos JD, Goodfield M, Caputo R, Papp K, Manjra A, Dobozy A, Paul C, Molloy S, Hultsch T, Graeber M, Cherill R, de Prost Y; Flare Reduction in Eczema with Elidel (Children) Multicenter Investigator Study Group. Efficacy and safety of pimecrolimus cream in the long-term management of atopic dermatitis in children. Pediatrics. 2002 Jul;110(1 Pt 1):e2. doi: 10.1542/peds.110.1.e2.

  PMID: 12093983 BACKGROUND

• Lee MJ, Pyszczynski N, Jusko WJ. Combined inhibition effects of tacrolimus and methylprednisolone on in vitro human lymphocyte proliferation. Immunopharmacol Immunotoxicol. 1995 May;17(2):335-45. doi: 10.3109/08923979509019755.

  PMID: 7544367 BACKGROUND

• Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8. doi: 10.1034/j.1600-0625.2001.100102.x.

  PMID: 11168575 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Fluticasone; pimecrolimus

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Jonathan Spergel
• Organization: The Children's Hospital of Philadelphia

spergel@email.chop.edu

215 590 1000

Study Officials

• Jonathan M Spergel, MD, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2005
• First Posted: July 13, 2005
• Study Start: October 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: July 27, 2010
• Results First Posted: July 22, 2010

Record last verified: 2010-07

Locations

US (3)