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A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Receive between 22 and 29 days of Cutivate lotion treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate 0.05% lotion | Drug | Daily applications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post Treatment Serum Cortisol Values Will be Compared. | The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression. | Up to 29 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity | The frequency distributions of the presence/absence of adverse events associated with signs of atrophy and pigmentation changes were summarized with frequency counts. Hematology and Chemistry Assessments were summarized in shift tables. Signs and symptoms of AD were summarized at each visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Fleischer Jr., M.D. | Wake Forest University Health Sciences | Principal Investigator |
| Lawrence F. Eichenfield, MD | Rady Children's Hospital, San Diego | Principal Investigator |
| Elizabeth Connelly, MD | University of Miami | Principal Investigator |
| Craig L. Leonardi, MD | Central Dermatology | Principal Investigator |
| Lawrence Parish, MD | Paddington Testing Company, Inc | Principal Investigator |
| Adelaide A Hebert, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Sharon Raimer, MD | University of Texas Medical Branch, Galveston | Principal Investigator |
| Kenneth E. Bloom, MD | Dermatology Center for Children and Young Adults | Principal Investigator |
| David L Kaplan, MD | Adult & Pediatric Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Health Care Medical Associates | Poway | California | 92064 | United States | ||
| Rady Children's Hospital, San Diego |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Receive between 22 and 29 days of Cutivate lotion treatment Fluticasone propionate 0.05% lotion: Daily applications |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Receive between 22 and 29 days of Cutivate lotion treatment Fluticasone propionate 0.05% lotion: Daily applications |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Post Treatment Serum Cortisol Values Will be Compared. | The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression. | Posted | Number | participants | Up to 29 days of treatment |
|
|
29 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Receive between 22 and 29 days of Cutivate lotion treatment Fluticasone propionate 0.05% lotion: Daily applications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA SOC |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA SOC |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela C. Kaplan | Fougera Pharmaceuticals Inc. | 631-659-2256 | angela.kaplan@sandoz.com |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29 |
| Stephen W. Shewmake, M.D. | Centre for Health Care Medical Associates | Principal Investigator |
| San Diego |
| California |
| 92123 |
| United States |
| University of Miami, Dept. of Dermatology | Miami | Florida | 33125 | United States |
| Adult & Pediatric Dermatology | Overland Park | Kansas | 66211 | United States |
| Dermatology Center for Children and Young Adults | Eagan | Minnesota | 55121-1176 | United States |
| Central Dermatology | St Louis | Missouri | 63117 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Paddington Testing Company, Inc | Philadelphia | Pennsylvania | 19103 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0783 | United States |
| University of Texas Health Science Center | Houston | Texas | 77030 | United States |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Number | participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity | The frequency distributions of the presence/absence of adverse events associated with signs of atrophy and pigmentation changes were summarized with frequency counts. Hematology and Chemistry Assessments were summarized in shift tables. Signs and symptoms of AD were summarized at each visit. | Posted | Number | participants | Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29 |
|
|
|
| 1 |
| 56 |
| 25 |
| 56 |
| Herpes simplex | Infections and infestations | MedDRA SOC |
|
| Nasopharyngitis | Infections and infestations | MedDRA SOC |
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| Upper respiratory tract infection | Infections and infestations | MedDRA SOC |
|
| Folliculitis | Infections and infestations | MedDRA SOC |
|
| Impetigo | Infections and infestations | MedDRA SOC |
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| Oral candidiasis | Infections and infestations | MedDRA SOC |
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| Otitis media | Infections and infestations | MedDRA SOC |
|
| Staphylococcal infection | Infections and infestations | MedDRA SOC |
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| Constipation | Gastrointestinal disorders | MedDRA SOC |
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| Diarrhoea | Gastrointestinal disorders | MedDRA SOC |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA SOC |
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| Teething | Gastrointestinal disorders | MedDRA SOC |
|
| Pyrexia | General disorders | MedDRA SOC |
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| Irritability | General disorders | MedDRA SOC |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA SOC |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA SOC |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA SOC |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA SOC |
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| Hypersensitivity | Immune system disorders | MedDRA SOC |
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| Ichthyosis | Congenital, familial and genetic disorders | MedDRA SOC |
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| Conjunctivitis | Eye disorders | MedDRA SOC |
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| Genital rash | Reproductive system and breast disorders | MedDRA SOC |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA SOC |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA SOC |
|
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |