Ignite Creation Date:
2024-05-11 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399783
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-05-01
Brief Title:
Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata Clinical Dermoscopic and Immunohistochemical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Alopecia areata AA is an autoimmune disorder characterized by non-scarring hair loss of the scalp or any hair-bearing surface
Alopecia areata affects approximately 2 of the general population AA has a significant influence on patients quality of life and may induce psychological disorders
In AA CD4 and CD8 T-cells violate the immune privilege of the anagen hair follicle leading to loss of the growing hair shaft A genome-wide association study demonstrated a genetic predisposition to AA Additionally environmental insults such as viral infections trauma or psychosocial stress have also been suspected to possibly contribute to the development of the disease
The clinical manifestations of AA vary from small well-defined patches of hair loss to the diffuse involvement of the scalp or the entire body The majority of AA patients experience unpredictable relapsing and remitting episodes In a number of patients it can be persistent especially when the hair loss is extensive
Alopecia areata affects approximately 2 of the general population AA has a significant influence on patients quality of life and may induce psychological disorders
In AA CD4 and CD8 T-cells violate the immune privilege of the anagen hair follicle leading to loss of the growing hair shaft A genome-wide association study demonstrated a genetic predisposition to AA Additionally environmental insults such as viral infections trauma or psychosocial stress have also been suspected to possibly contribute to the development of the disease
The clinical manifestations of AA vary from small well-defined patches of hair loss to the diffuse involvement of the scalp or the entire body The majority of AA patients experience unpredictable relapsing and remitting episodes In a number of patients it can be persistent especially when the hair loss is extensive
Detailed Description:
There are many treatment modalities for AA including topical treatment intralesional injections systemic corticosteroids systemic immunosuppressants like methotrexate or cyclosporine excimer laser and photochemotherapy To date the majority of traditional treatments for AA are of limited efficacy with a high risk of adverse effects
Topical corticosteroids are widely used in the treatment of limited patchy AA and as a first-line therapy for children They are also recommended as an adjunctive therapy to systemic treatments in more severe forms
Statins are well known lipid-lowering medications They have anti-inflammatory and immunomodulatory effects Simvastatin belongs to the statin family Lately Simvastatin is utilized in treatment of several dermatological diseases It showed efficacy in treatment of psoriasis vitiligo xanthomas atopic dermatitis and acne vulgaris
In several case reports AA patients were successfully treated with systemic simvastatin DelCanto 2020 studied the effect of topical simvastatin in animal model of AA and concluded that it induced hair re-growth suggesting that it could be a new efficient therapy for AA
Statins are theorized to induce hair regrowth in AA by inhibiting signal transducers and activators of transcription STAT phosphorylation that activates several important inflammatory cytokines and also by altering the balance of Th1Th2 suppressing IL-17 and inhibiting lymphocyte migration
Fractional laser has been reported to be successful in treating AA Fractional CO2 laser is assumed to help in treatment of AA through stimulation of T-cell apoptosis arrest of hair follicles in the telogen stage and promotion of the anagen stage Also Fractional CO2 laser creates microchannels in the epidermis to improve drug delivery into the skin
Topical corticosteroids are widely used in the treatment of limited patchy AA and as a first-line therapy for children They are also recommended as an adjunctive therapy to systemic treatments in more severe forms
Statins are well known lipid-lowering medications They have anti-inflammatory and immunomodulatory effects Simvastatin belongs to the statin family Lately Simvastatin is utilized in treatment of several dermatological diseases It showed efficacy in treatment of psoriasis vitiligo xanthomas atopic dermatitis and acne vulgaris
In several case reports AA patients were successfully treated with systemic simvastatin DelCanto 2020 studied the effect of topical simvastatin in animal model of AA and concluded that it induced hair re-growth suggesting that it could be a new efficient therapy for AA
Statins are theorized to induce hair regrowth in AA by inhibiting signal transducers and activators of transcription STAT phosphorylation that activates several important inflammatory cytokines and also by altering the balance of Th1Th2 suppressing IL-17 and inhibiting lymphocyte migration
Fractional laser has been reported to be successful in treating AA Fractional CO2 laser is assumed to help in treatment of AA through stimulation of T-cell apoptosis arrest of hair follicles in the telogen stage and promotion of the anagen stage Also Fractional CO2 laser creates microchannels in the epidermis to improve drug delivery into the skin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None