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| Name | Class |
|---|---|
| DPT Laboratories, Ltd. | INDUSTRY |
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To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.
To establish superiority of each active treatment over the placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days |
|
| Reference Standard | Active Comparator | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days |
|
| Placebo | Placebo Comparator | Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimecrolimus Cream, 1% | Drug |
| ||
| Placebo Cream |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting | Day 15 |
| Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Severity of Four Individual Signs and Symptoms | Erythema, induration/papulation, lichenification and pruritus | Day 15 |
| Evaluation of Application Site Reactions | Dryness, burning/stinging, erosion, edema, and pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility 6 | Boynton Beach | Florida | 33437 | United States | ||
| Research Facility 4 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days Pimecrolimus Cream, 1% |
| FG001 | Reference Standard | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days Pimecrolimus Cream, 1% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 14, 2016 | Feb 25, 2020 |
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|
| Pimecrolimus Cream, 1% | Drug |
|
|
| Day 15 |
| Coral Gables |
| Florida |
| 33146 |
| United States |
| Research Facility 5 | Miami | Florida | 33144 | United States |
| Research Facility 10 | Miami | Florida | 33175 | United States |
| Research Facility 1 | Miami Lakes | Florida | 33014 | United States |
| Research Facility 9 | Miramar | Florida | 33027 | United States |
| Research Facility 33 | Sweetwater | Florida | 33172 | United States |
| Research Facility 23 | Boise | Idaho | 83704 | United States |
| Research Facility 28 | Overland Park | Kansas | 66215 | United States |
| Research Facility 32 | Louisville | Kentucky | 40241 | United States |
| Research Facility 13 | New Orleans | Louisiana | 70115 | United States |
| Research Facility 7 | Saint Joseph | Missouri | 64506 | United States |
| Research Facility 19 | Omaha | Nebraska | 68114 | United States |
| Research Facility 29 | Albuquerque | New Mexico | 87106 | United States |
| Research Facility 24 | Charlotte | North Carolina | 28277 | United States |
| Research Facility 2 | High Point | North Carolina | 27262 | United States |
| Resarch Facility 8 | Philadelphia | Pennsylvania | 19103 | United States |
| Research Facility 18 | Johnston | Rhode Island | 02919 | United States |
| Research Facility 20 | Austin | Texas | 78759 | United States |
| Research Facility 16 | College Station | Texas | 77845 | United States |
| Research Facility 31 | Pflugerville | Texas | 78660 | United States |
| Research Facility 17 | Sugar Land | Texas | 77479 | United States |
| Research Facility 22 | West Jordan | Utah | 84088 | United States |
| Research Facility 15 | Richmond | Virginia | 23220 | United States |
| Research Facility 26 | Spokane | Washington | 99202 | United States |
| Research Facility 11 | Santo Domingo | Dominican Republic |
| Research Facility 12 | San Pedro Sula | Honduras |
| FG002 | Placebo | Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days Placebo Cream |
| Dosed | 2 Test, 2 Reference, and 1 Placebo Subjects are not known to have dosed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety
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| ID | Title | Description |
|---|---|---|
| BG000 | Test | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days Pimecrolimus Cream, 1% |
| BG001 | Reference Standard | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days Pimecrolimus Cream, 1% |
| BG002 | Placebo | Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days Placebo Cream |
| BG003 | 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 | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Investigator's Global Assessement of Severity | Count of Participants | Participants |
|
| 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 | Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting | Modified ITT (Intent-to-treat) sample | Posted | Count of Participants | Participants | Day 15 |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting | PP (per protocol) sample | Posted | Count of Participants | Participants | Day 15 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Severity of Four Individual Signs and Symptoms | Erythema, induration/papulation, lichenification and pruritus | PP sample | Posted | Count of Participants | Participants | Day 15 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Evaluation of Application Site Reactions | Dryness, burning/stinging, erosion, edema, and pain | Safety with data for this parameter | Posted | Count of Participants | Participants | Day 15 |
|
|
Day 15
Serious Adverse Event: substantial disruption of the ability to conduct normal functions was not included in the study protocol definition
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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 | Test | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days Pimecrolimus Cream, 1% | 0 | 215 | 0 | 215 | 0 | 215 |
| EG001 | Reference Standard | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days Pimecrolimus Cream, 1% | 0 | 214 | 0 | 214 | 0 | 214 |
| EG002 | Placebo | Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days Placebo Cream | 0 | 220 | 0 | 220 | 0 | 220 |
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The publication rights for the data generated rests with the sponsor. The site retains the right to use such data or results for its own publication only upon getting the written approval from the sponsor, only after the first publication of such data by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prasanna C Ganapathi, Clinical Sciences Program Lead | Mylan Pharmaceuticals Pvt Ltd | +91 9148448200 | PrasannaC.Ganapathi@mylan.in |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2017 | Feb 25, 2020 | SAP_001.pdf |
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C117268 | pimecrolimus |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Moderate |
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| Superiority |
|
|
|
|
|
| 1 = Worsen by 1 |
|
| 0 = No change |
|
| -1 = Improve by 1 |
|
| -2 = Improve by 2 |
|
| -3 = Improve by 3 |
|
| 1 = Worsen by 1 |
|
| 0 = No change |
|
| -1 = Improve by 1 |
|
| -2 = Improve by 2 |
|
| -3 = Improve by 3 |
|
| 1 = Worsen by 1 |
|
| 0 = No change |
|
| -1 = Improve by 1 |
|
| -2 = Improve by 2 |
|
| -3 = Improve by 3 |
|
| 1 = Worsen by 1 |
|
| 0 = No change |
|
| -1 = Improve by 1 |
|
| -2 = Improve by 2 |
|
| -3 = Improve by 3 |
|
| 1 = Worsen by 1 |
|
| 0 = No change |
|
| -1 = Improve by 1 |
|
| -2 = Improve by 2 |
|
| -3 = Improve by 3 |
|
| 1 = Worsen by 1 |
|
| 0 = No change |
|
| -1 = Improve by 1 |
|
| -2 = Improve by 2 |
|
| -3 = Improve by 3 |
|
| 1 = Worsen by 1 |
|
| 0 = No change |
|
| -1 = Improve by 1 |
|
| -2 = Improve by 2 |
|
| -3 = Improve by 3 |
|
| 1 = Worsen by 1 |
|
| 0 = No change |
|
| -1 = Improve by 1 |
|
| -2 = Improve by 2 |
|
| -3 = Improve by 3 |
|
| 1 = Worsen by 1 |
|
| 0 = No change |
|
| -1 = Improve by 1 |
|
| -2 = Improve by 2 |
|
| -3 = Improve by 3 |
|
| 1 = Worsen by 1 |
|
| 0 = No change |
|
| -1 = Improve by 1 |
|
| -2 = Improve by 2 |
|
| -3 = Improve by 3 |
|
| 1 = Worsen by 1 |
|
| 0 = No change |
|
| -1 = Improve by 1 |
|
| -2 = Improve by 2 |
|
| -3 = Improve by 3 |
|
| 1 = Worsen by 1 |
|
| 0 = No change |
|
| -1 = Improve by 1 |
|
| -2 = Improve by 2 |
|
| -3 = Improve by 3 |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|