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

April 2, 2024 updated by: Alshayma Gamal Fouad, South Valley University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 34.7%. Females significantly reported acne more frequently than males (39.1% vs. 30.3%) Prevalence of clinically confirmed acne was 24.4%, with higher rates among females (28.6%) than males (20.2%).

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Healthy patients with Age and sex matching ,No history of acne, serum level of intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA)
Active Comparator: group moderate acne
patients with moderate acne vulgaris who will receive Montelukast therapy dose: 10mg/day, duration of therapy: three months, serum level of intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA) before and after treatment
Drug: 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
Other Names:
  • level of serum intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA)
Active Comparator: group severe acne
patients with severe acne vulgaris who will receive Montelukast therapy dose: 10mg/day, duration of therapy: three months, serum level of intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA) before and after treatment
Drug: 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
Other Names:
  • level of serum intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris (moderate -severe )
Time Frame: baseline and three months at the end of treatment
evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level by ELISA in acne vulgaris(moderate -severe) and compare it to control group, correlation with acne vulgaris severity and its role in pathogenesis
baseline and three months at the end of treatment
Montelukast in treatment of acne vulgaris patients
Time Frame: three months following end of treatment
Evaluate the effect of Montelukast on serum (sICAM-1) level in acne vulgaris (group moderate acne vs group severe acne )and its side effects
three months following end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • Study Director: Abdulrahman Abdul Hamid Alsaied, Professor, South Valley University
  • Study Director: Hassan Mohammed Ibrahim, Assistant Professor, South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sICAM-1 in acne vulgaris

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acne Vulgaris

Clinical Trials on Montelukast 10 Mg Oral Tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe