Phase 4 N=90 Randomized Double-blind Treatment

Combination Therapy for Atopic Dermatitis

Atopic Dermatitis

Bottom Line

View on ClinicalTrials.gov: NCT00119158 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2010

Primary outcome: Primary: Change From Baseline in the m-EASI (Eczema Area Severity Index) Score. — 5.04; 4.77 units of a 0-12 scale — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Combination of pimecrolimus and fluticasone (Drug); pimecrolimus (Drug)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: Children's Hospital of Philadelphia
Primary completion: Jun 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the m-EASI (Eczema Area Severity Index) Score.	5.04; 4.77	<0.05 sig
SECONDARY The Time to Clearance of the Disease	9.22; 7.88	—
SECONDARY The Time to the First Day When m-EASI is Scored by the Investigator as 2 or Less	—	—
SECONDARY The Percentage of Target Areas Reaching a l-IGA (Localized Investigator Global Assessment (l-IGA) or 0 or 1)	—	—
SECONDARY The Percentage of Target Areas Improved (i.e., Decrease in Localized Investigator Global Assessmet (l-IGA) Score From Baseline)	—	—
SECONDARY The Percentage of Target Areas Reaching a m-EASI (Modifed-Eczema Area Severity Index) Score of 2 or Less	—	—
SECONDARY Change From Baseline in Patients' Self Assessment of Disease Severity (PSA) of Target Areas	—	—

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 Criteria

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)

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00119158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.