Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Pimecrolimus |
|
| 2 | Active Comparator | Corticosteroid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimecrolimus | Drug | Pimecrolimus cream 1 % |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Atopic Dermatitis (AD) Disease Control Over 36 Months | Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement. | 36 months |
| Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age | Note: The results for this efficacy variable are not reported due to early termination of the study. | 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Long Term Safety in Infants and Young Children | Note: The results of this secondary outcome is not reported due to early termination of the study. | 6 years |
| Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol related criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Allergy and Asthma Center | Birmingham | Alabama | 35209 | United States | ||
| Northwest Arkansas Pediatric Clinic, P.A. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26598458 | Derived | Spergel JM, Boguniewicz M, Schneider L, Hanifin JM, Paller AS, Eichenfield LF. Food Allergy in Infants With Atopic Dermatitis: Limitations of Food-Specific IgE Measurements. Pediatrics. 2015 Dec;136(6):e1530-8. doi: 10.1542/peds.2015-1444. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pimecrolimus (Elidel) Treatment Group | Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue |
| FG001 | Control Treatment Group | Management with vehicle/topical corticosteroid rescue. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Corticosteroid |
| Drug |
conventional corticosteroid-based treatment |
|
Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study.
Note: The results at six years are not reported due to early termination of the study.
| 6 years (36 month Double-Blind Phase) |
| Corticosteroid and Pimecrolimus Drug Use | Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase. Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months. | 48 months |
| Atopic Dermatitis (AD) Remission Time | Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response ("yes") to the question "No or almost no eczema?" and a response of no treatment except emollients to the question "Medication used". | 36 month Double-Blind Phase |
| Patient/Caregiver Quality of Life | Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) * 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life. | From Baseline to Visit 5 , 6, 8, 10, 12, and 14 |
| Fayetteville |
| Arkansas |
| 72703 |
| United States |
| The Children's Clinic of Jonesboro | Jonesboro | Arkansas | 72401 | United States |
| Southern California Research | Mission Viejo | California | 92691 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Stanford Dermatology Clinic and Clinical Trials Dept | Redwood City | California | 94063 | United States |
| Capital Allergy Respiratory Disease Center | Sacramento | California | 95819 | United States |
| Children's Hospital San Diego | San Diego | California | 92123 | United States |
| Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division | Walnut Creek | California | 94598 | United States |
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | United States |
| Dermatology Associates and Research | Coral Gables | Florida | 33134 | United States |
| Emerald Coast Clinical Research | Pensacola | Florida | 32503 | United States |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | United States |
| Indiana University Outpatient Clinical Research | Indianapolis | Indiana | 46202 | United States |
| Central Kentucky Research Associates | Lexington | Kentucky | 40509 | United States |
| Dermatology Specialists | Louisville | Kentucky | 40202 | United States |
| Rx R & D | Metarie | Louisiana | 70002 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Children's Hospital - Boston | Boston | Massachusetts | 02115 | United States |
| Dermatology, PLLC | Ann Arbor | Michigan | 48103 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Central Dermatology | St Louis | Missouri | 63117 | United States |
| Skin Specialists, P.C. | Omaha | Nebraska | 68144 | United States |
| Dartmouth-Hitchcock Medical Center/Dermatology Section | Lebanon | New Hampshire | 03756 | United States |
| Children's Medical Group | Hopewell Junction | New York | 12533 | United States |
| Dermatology Associates of St. Luke's - Roosevelt | New York | New York | 10025 | United States |
| Calcagno Research and Development | Gresham | Oregon | 97030 | United States |
| Oregon Health Science University - Dermatology Dept. | Portland | Oregon | 97201 | United States |
| The Childrens' Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Texas Children's Hospital, BCM | Houston | Texas | 77030 | United States |
| Alpine Medical Group, LLC | Salt Lake City | Utah | 84102 | United States |
| Granger Medical Clinic | West Valley City | Utah | 84120 | United States |
| Virginia Clinical Research | Norfolk | Virginia | 23507 | United States |
| Asthma Inc | Seattle | Washington | 98105 | United States |
| Patients Who Received Study Medication |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pimecrolimus (Elidel) Treatment Group | Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue |
| BG001 | Control Treatment Group | Management with vehicle/topical corticosteroid rescue. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | months |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Parents' Index of Quality of Life - Atopic Dermatitis Score | Parents' Index Quality of Life - Atopic Dermatitis (PIQoL-AD) score = (sum of valid items/number of valid items)*28. Scores range from a total possible minimum value of 0 to a maximum value of 28, with a high total overall score indicating poor quality of life. | Mean | Standard Deviation | Scores on PIQoL-AD Scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Atopic Dermatitis (AD) Disease Control Over 36 Months | Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement. | Intent to Treat Population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement. | Posted | Mean | Standard Deviation | Proportion of disease free days | 36 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age | Note: The results for this efficacy variable are not reported due to early termination of the study. | Not Posted | 6 years | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Long Term Safety in Infants and Young Children | Note: The results of this secondary outcome is not reported due to early termination of the study. | Not Posted | 6 years | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies | Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study. Note: The results at six years are not reported due to early termination of the study. | Intent to Treat Population defined as all randomized patients who were dispensed study medication and had at least one post-baseline efficacy measurement. | Posted | Number | Percentage of Participants | 6 years (36 month Double-Blind Phase) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Corticosteroid and Pimecrolimus Drug Use | Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase. Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months. | Safety population: all randomized patients who were dispensed study medication. | Posted | Mean | Standard Deviation | Days of Exposure | 48 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Atopic Dermatitis (AD) Remission Time | Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response ("yes") to the question "No or almost no eczema?" and a response of no treatment except emollients to the question "Medication used". | Intent-to-Treat population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement. | Posted | Mean | Standard Deviation | Days | 36 month Double-Blind Phase |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient/Caregiver Quality of Life | Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) * 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life. | Intent-to-Treat Population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement. | Posted | Mean | Standard Deviation | Scores on PIQoL-AD Scale | From Baseline to Visit 5 , 6, 8, 10, 12, and 14 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pimecrolimus (Elidel) Treatment Group | Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue | 42 | 543 | 482 | 543 | ||
| EG001 | Control Treatment Group | Management with vehicle/topical corticosteroid rescue. | 37 | 544 | 467 | 544 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Croup, infectious | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Lymph node abscess | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Tonsillitis, streptococcal | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Beta hemolytic streptococcal infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Eczema, infected | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Laryngotracheo bronchitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Pneumonia, bacterial | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Bronchial hyper-reactivity | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Epiglottic edema | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Food Allergy | Immune system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Febrile convulsions | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Post procedural hemorrhage | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Hepatic trauma | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Subdural hematoma | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Von Willebrand's disease | Congenital, familial and genetic disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Nephroblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Prepuce redundant | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Retinal hemorrhage | Eye disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (9.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Conjunctivitis, bacterial | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Food Allergy | Immune system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Conjunctivitis, allergic | Eye disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (9.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D003872 | Dermatitis |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
Not provided
Not provided
| ID | Term |
|---|---|
| C117268 | pimecrolimus |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| 3 months to Less than 6 months |
|
| 6 months to Less than 12 months |
|
| 12 months to Less than or equal to 18 months |
|
| Greater than 18 months |
|
| Male |
|
|
|
|
|