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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This trial is a single-center two arm, open label observational prospective study, that will evaluate the safety and efficacy of crisaborole ointment, 2% alone compared to a combination therapy of crisaborole and a topical corticosteroid (Triamcinolone Acetonide Ointment, 0.1%) over a 8 week period for the treatment of mild to moderate atopic dermatitis.
Male and female subjects, ages 2 to 79 with mild to moderate atopic dermatitis and having an Investigator's Global Assessment Score on a five point scale of 2 or 3 will be enrolled.
Sixteen subjects will be enrolled and randomized 1:1. Eight subjects will be randomized to receive crisaborole alone which will be applied twice daily, once in the morning and once in the evening for 8 weeks. Eight subjects will be randomized to receive a combination therapy of a topical corticosteroid (Triamcinolone Acetonide Ointment, 0.1% and crisaborole ointment, 2% which will be applied twice a day, once in the morning and once in the evening for the first two weeks, followed by crisaborole alone for the following six weeks.
Subjects who meet the inclusion criteria and none of the exclusion criteria at the Screening visit will return to the clinic on Week 0 for Baseline measures and to start treatment which will continue for a period of 8 weeks. Subjects who do not need to undergo a wash-out period may combine the Screening visit and Baseline visit.
Screened subjects requiring a wash-out period (up to 4 weeks) prior to baseline measurements and beginning treatment will attend a total of 4 visits.
Following the Baseline (Week 0) visit, all subjects will report to the clinic for efficacy and safety evaluations at weeks 2, 4 and at the end of study at week 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crisaborole 2% Topical Application Ointment [EUCRISA] | Crisaborole 2% Topical Application Ointment [EUCRISA] applied twice a day for 8 weeks |
| |
| Crisaborole 2% plus Triamcinolone Acetonide 0.1%Ointment | Crisaborole 2% plus Triamcinolone Acetonide 0.1% Ointment applied twice a day for the first 2 weeks, followed by Crisaborole 2% alone applied twice a day for the following 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisaborole 2% Topical Application Ointment [EUCRISA] | Drug | Ointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment | 2 grade or greater improvement from baseline | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Patient Itching | Visual Analog Scale (1-10) for Itching improvement | Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
during the defined period are as listed below. If a patient requires any of these medications throughout the study period, he/she may be excluded from or discontinued from the study, at the discretion of the Investigator and medical monitor. • From 6 Months prior to the first application of the study drug: Biological products that might have significantly affected the evaluation of atopic dermatitis condition (e.g., tumor necrosis factor [TNF] inhibitors, antiimmunoglobulin [Ig]E antibodies, anti-CD20 antibodies, anti-interleukin [IL]-4 receptor
• From 21 days prior to the first application of study drug: Corticosteroid preparations (oral, injection, and suppository preparations) and topical corticosteroids that were classified as super-high potency (clobetasol propionate).
Oral preparations and injections of immunosuppressants (cyclosporine, methotrexate, azathioprine, tacrolimus, etc.); Excessive sun exposure, tanning booth, other ultraviolet (UV) light source and phototherapy including psoralen and ultraviolet A (PUVA) therapy. • From 14 days prior to the first application of the study drug: any other topical phosphodiesterase 4 (PDE4) inhibitor; Tacrolimus and pimecrolimus cream and/or ointment; Topical corticosteroids that were classified as low, medium, or high potency (e.g., fluocinonide, triamcinolone acetonide, desonide, hydrocortisone).
Eye drops and nasal preparations are allowed.
• From 7 days prior to the first application of the study drug: Oral or intravenous antibiotics, antifungal or antivirus medications Antihistamines/anti-allergics (oral, topical and injections): diphenhydramine, chlorpheniramine maleate, hydroxyzine).
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Male and female patients age 2 to 79 years of age with confirmed diagnosis of atopic dermatitis
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| Name | Affiliation | Role |
|---|---|---|
| Todd Schlesinger, MD | Clinical Research Center of the Carolinas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of the Carolinas | Charleston | South Carolina | 29407 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26377142 | Background | Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016 Mar 12;387(10023):1109-1122. doi: 10.1016/S0140-6736(15)00149-X. Epub 2015 Sep 13. | |
| 29033598 | Background | Patel NU, Felix K, Reimer D, Feldman SR. Calcipotriene/betamethasone dipropionate for the treatment of psoriasis vulgaris: an evidence-based review. Clin Cosmet Investig Dermatol. 2017 Sep 29;10:385-391. doi: 10.2147/CCID.S131727. eCollection 2017. |
| Label | URL |
|---|---|
| NDA 207695 Risk Assessment Review | View source |
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| Triamcinolone Acetonide 0.1% Ointment | Drug | Topical Corticosteroid |
|
| Background | PL McCormack - American journal of clinical dermatology, 2011 - Springer |
| NDA 207695 Clinical Review | View source |
| Crisaborole FULL PRESCRIPTION INFORMATION | View source |
| 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 |
|---|---|
| C543085 | crisaborole |
| D014222 | Triamcinolone Acetonide |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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