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Clinical trial

Role of Intercellular Adhesion Molecule -1 in Acne Vulgaris Patients : Effect of Montelukast Therapy

ID
Name
sICAM-1 in acne vulgaris
Description
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
Trial arms
Trial start
2024-06-01
Estimated PCD
2024-11-01
Trial end
2025-02-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Montelukast 10 Mg Oral Tablet
group modrate and severe acne will receive Montelukast therapy , dose: 10mg/day, duration of therapy: three months., Quantitively assay of level of serum intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA) in group moderate acne vs group severe acne pre Montelukast treatment and after three months of treatment vs control group
Arms:
group moderate acne, group severe acne
Other names:
level of serum intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA)
Size
60
Primary endpoint
Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris (moderate -severe )
baseline and three months at the end of treatment
Montelukast in treatment of acne vulgaris patients
three months following end of treatment
Eligibility criteria
Inclusion Criteria: * Healthy persons of both sexes with moderate and severe acne vulgaris. * Patients age between 15-35 years * Patients with acne vulgaris not receiving any topical or systemic treatments for acne at least 2 weeks and 2 month before the study ,respectively Exclusion Criteria: * Pregnant and lactating women * Diabetics * Hypertensive patients * acne conglobate patients and acne fulminans patients * patients with history of polycystic ovaries syndrome * Patients with history of thyroid dysfunction * Patients with history of chronic inflammatory or immune-mediated diseases as Crohn's disease, vascular dementia, systemic sclerosis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis and SAPHO syndrome. * Any history of hypersensitivity reaction to the studied drug
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-04-03

1 organization

1 product

1 indication

Organization
South Valley University
Product
Montelukast
Indication
Acne Vulgaris