Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340984
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-26
Brief Title:
Serum Intercellular Adhesion Molecule -1 in Acne Vulgaris Patients Effect of Montelukast
Sponsor:
South Valley University
Organization:
South Valley University
Study Overview
Official Title:
Role of Intercellular Adhesion Molecule -1 in Acne Vulgaris Patients Effect of Montelukast Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
The aim of this study is to
1 Evaluation of serum soluble intercellular adhesion molecule-1 sICAM-1 level in acne vulgaris and compare it to control group
2 Evaluate its role in acne pathogenesis and its correlation with acne vulgaris severity
3 Evaluate the effect of Montelukast on serum sICAM-1 level in acne vulgaris
1 Evaluation of serum soluble intercellular adhesion molecule-1 sICAM-1 level in acne vulgaris and compare it to control group
2 Evaluate its role in acne pathogenesis and its correlation with acne vulgaris severity
3 Evaluate the effect of Montelukast on serum sICAM-1 level in acne vulgaris
Detailed Description:
Acne vulgaris is a common chronic skin disease involving blockage and inflammation of pilosebaceous units
It is characterized by non-inflammatory open or closed comedones and by inflammatory lesions include papules pustules and nodules Affecting mostly the face but also the back and chest
Acne vulgaris may have a psychological impact on any patient regardless of the severity or the grade of the disease
Prevalence of self-reported acne was 347 Females significantly reported acne more frequently than males 391 vs 303 Prevalence of clinically confirmed acne was 244 with higher rates among females 286 than males 202
Its pathogenesis result from increased sebum production due to increased activity of androgens and insulin growth factor-1 excessive deposition of keratin in pilosebaceous follicles leading to comedo formation colonization of the follicle by Propionibacterium acnes bacteria and the local release of pro-inflammatory chemicals in the skin through certain inflammatory mechanisms
Recently Inflammation is a key feature in the pathogenesis of acne vulgaris with various chemokines and cytokines that contribute to fuel a vicious cycle
Leukotriene B4 LT-B4 is the most potent leucocyte chemotactic mediator in the pathogenesis of acne Intercellular adhesion molecule-1 ICAM-1 is a transmembrane glycoprotein in the immunoglobulin superfamily that increases in response to various inflammation mediator In addition genetics is also a key factor in the pathophysiology of acne
There are various topical therapies for acne vulgaris including topical retinoids antimicrobials benzoyl peroxide salicylic acid lactic acid dapsone and niacinamide Moderate to severe acne is treated with oral antibiotics especially tetracyclines and isotretinoin is prescribed for severe acne unresponsive to antibiotics
Montelukast is an antagonist of LT-B4 receptor Montelukast has good efficacy tolerability and safety in the treatment of acne
It is characterized by non-inflammatory open or closed comedones and by inflammatory lesions include papules pustules and nodules Affecting mostly the face but also the back and chest
Acne vulgaris may have a psychological impact on any patient regardless of the severity or the grade of the disease
Prevalence of self-reported acne was 347 Females significantly reported acne more frequently than males 391 vs 303 Prevalence of clinically confirmed acne was 244 with higher rates among females 286 than males 202
Its pathogenesis result from increased sebum production due to increased activity of androgens and insulin growth factor-1 excessive deposition of keratin in pilosebaceous follicles leading to comedo formation colonization of the follicle by Propionibacterium acnes bacteria and the local release of pro-inflammatory chemicals in the skin through certain inflammatory mechanisms
Recently Inflammation is a key feature in the pathogenesis of acne vulgaris with various chemokines and cytokines that contribute to fuel a vicious cycle
Leukotriene B4 LT-B4 is the most potent leucocyte chemotactic mediator in the pathogenesis of acne Intercellular adhesion molecule-1 ICAM-1 is a transmembrane glycoprotein in the immunoglobulin superfamily that increases in response to various inflammation mediator In addition genetics is also a key factor in the pathophysiology of acne
There are various topical therapies for acne vulgaris including topical retinoids antimicrobials benzoyl peroxide salicylic acid lactic acid dapsone and niacinamide Moderate to severe acne is treated with oral antibiotics especially tetracyclines and isotretinoin is prescribed for severe acne unresponsive to antibiotics
Montelukast is an antagonist of LT-B4 receptor Montelukast has good efficacy tolerability and safety in the treatment of acne
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