Combination Therapy for Atopic Dermatitis
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| ClinicalTrials.gov Identifier: NCT00119158 |
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Recruitment Status :
Completed
First Posted : July 13, 2005
Results First Posted : July 22, 2010
Last Update Posted : July 27, 2010
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atopic Dermatitis | Drug: Combination of pimecrolimus and fluticasone Drug: pimecrolimus | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | An Exploratory Double-blind, Randomized, Vehicle-controlled, Paired Study to Evaluate the Efficacy and Safety of Concomitant Use of Elidel Cream 1% and Cutivate Cream 0.05% in Patients With Severe Lesions of Atopic Dermatitis (AD) |
| Study Start Date : | October 2004 |
| Actual Primary Completion Date : | June 2005 |
| Actual Study Completion Date : | June 2005 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: placebo
Placebo cream
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Drug: pimecrolimus
apply daily with fluticasone cream for flares |
| Active Comparator: pimecrolimus cream |
Drug: Combination of pimecrolimus and fluticasone
Pimecrolimus cream twice a day and fluticasone cream once a day
Other Names:
Drug: pimecrolimus apply daily with fluticasone cream for flares |
- Change From Baseline in the m-EASI (Eczema Area Severity Index) Score. [ Time Frame: up to 15 days ]
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
- The Time to Clearance of the Disease [ Time Frame: assessed up to 30 days following drug application ]The time to clearance of eczema measured in days
- The Time to the First Day When m-EASI is Scored by the Investigator as 2 or Less [ Time Frame: up to one week ]Time to partial clearance of the localized eczema lesion assessed by the investigator is measured in days
- The Percentage of Target Areas Reaching a l-IGA (Localized Investigator Global Assessment (l-IGA) or 0 or 1) [ Time Frame: up to 15 days ]The Investigator Global Assessment (IGA) and l-IGA were graded on a scale of 0-4 (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe). The percentage of eczema lesions from the total population that reach almost clear
- The Percentage of Target Areas Improved (i.e., Decrease in Localized Investigator Global Assessmet (l-IGA) Score From Baseline) [ Time Frame: up to 15 days ]
The percentage of eczema areas that show improvement in l-IGA score.
The l-IGA were graded on a scale of 0-4 (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease).
- The Percentage of Target Areas Reaching a m-EASI (Modifed-Eczema Area Severity Index) Score of 2 or Less [ Time Frame: up to one week ]
The EASI is a measure of Atopic Dermatitis (AD) severity. A m-EASI score (0-12) was also calculated as the sum of severity (0 = mild to 3 = severe) for four separate AD symptoms: erythema, infiltration ⁄population, excoriation and lichenification.
The percentage of participants whose eczema reaches almost clear
- Change From Baseline in Patients' Self Assessment of Disease Severity (PSA) of Target Areas [ Time Frame: 30 days ]
The patient or caregiver assessment of eczema severity (PSA) was recorded daily in a diary using a 0-4 scale similar to that of the IGA.(0 = clear,
1 = almost clear, 2 = mild disease, 3 = moderate disease,4 = severe disease).
Difference in value of PSA from baseline to end of study
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| Ages Eligible for Study: | 2 Years to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119158
| United States, Colorado | |
| National Jewish Research Medical Center | |
| Denver, Colorado, United States, 80206 | |
| United States, Illinois | |
| Northwestern University School of Medicine | |
| Chicago, Illinois, United States, 60611 | |
| United States, Texas | |
| University of Texas at Houston Medical School | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Jonathan M Spergel, MD, PhD | Children's Hospital of Philadelphia |
Publications:
| Responsible Party: | Jonathan Spergel, The Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT00119158 History of Changes |
| Other Study ID Numbers: |
2004-10-3975 |
| First Posted: | July 13, 2005 Key Record Dates |
| Results First Posted: | July 22, 2010 |
| Last Update Posted: | July 27, 2010 |
| Last Verified: | July 2010 |
Keywords provided by Children's Hospital of Philadelphia:
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THerapy for acute moderate to severe flares |
Additional relevant MeSH terms:
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Dermatitis Dermatitis, Atopic Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pimecrolimus Fluticasone Tacrolimus Anti-Inflammatory Agents Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Antirheumatic Agents Immunosuppressive Agents Immunologic Factors Calcineurin Inhibitors |