Ignite Creation Date:
2024-05-06 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03567980
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
2018-06-11
Brief Title:
A Proof of Concept Clinical Trial Evaluating the Safety and Efficacy of Eucrisa Crisaborole in Patients With Seborrheic Dermatitis
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Proof of Concept Clinical Trial Evaluating the Safety and Efficacy of Eucrisa Crisaborole in Patients With Seborrheic Dermatitis
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Seborrheic dermatitis is a common and recurrent dermatosis that characteristically involves the scalp nasolabial folds eyebrows glabella and upper eye lids It presents as an erythematous thin scaly patch with a greasy sandpaper texture that varies depending on disease severity While seborrheic dermatitis most frequently occurs on the face it can involve other areas of the body especially the chest abdomen and axilla Overall incidence is thought to be between 2-5 of the general population though this is likely an underestimation Pruritus is variable though the signs and symptoms of this disorder are certainly worsened by certain external conditions especially weather personal perspiration stress and poor hygiene Patients often complain about the red scaly patches on the face
Antifungal agents are frequently used as monotherapy or in combination regimens in the treatment of seborrheic dermatitis Topical corticosteroids are often used for their anti-inflammatory effects Long term use of topical steroids on the face is not a preferred treatment modality due to the risk of striae development and other textural changes that occur over time Therefore topical crisaborole may be an alternative given its non-corticosteroid anti-inflammatory action Crisaborole is a phosphodiesterase-4 PDE-4 inhibitor that increases intracellular cyclic AMP cAMP levels to exert its anti-inflammatory effects While it has not previously been investigated for its effects in seborrheic dermatitis further studies evaluating its role in this disease are warranted
Therefore the investigators propose a proof of concept study using topical crisaborole 2 ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis
Antifungal agents are frequently used as monotherapy or in combination regimens in the treatment of seborrheic dermatitis Topical corticosteroids are often used for their anti-inflammatory effects Long term use of topical steroids on the face is not a preferred treatment modality due to the risk of striae development and other textural changes that occur over time Therefore topical crisaborole may be an alternative given its non-corticosteroid anti-inflammatory action Crisaborole is a phosphodiesterase-4 PDE-4 inhibitor that increases intracellular cyclic AMP cAMP levels to exert its anti-inflammatory effects While it has not previously been investigated for its effects in seborrheic dermatitis further studies evaluating its role in this disease are warranted
Therefore the investigators propose a proof of concept study using topical crisaborole 2 ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None