Measurement of Serum microRNA in Acne Vulgaris Patient

July 2, 2023 updated by: Alshayma Gamal Fouad, South Valley University

Evaluation of Serum MicroRNA in Acne Vulgaris and Relation to Acne Severity

The aim of the study is to:

  1. Evaluation of serum microRNA in acne vulgaris and compare to control group
  2. Evaluate correlation with acne vulgaris severity

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.

Acne vulgaris 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%).(4) the pathogenesis result from increased sebum production (due to increased activity of androgens and (IGF-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.

In addition, genetics is also a key factor in the pathophysiology of acne. MicroRNAs(MiRNAs) are a class of endogenous, short (19-23 nucleotides in length), which regulate the expression of genes via translational repression or degradation of target messenger RNAs.Recently, the role of miRNAs has also been reviewed for the pathogenesis of various inflammatory skin conditions such as psoriasis, eczema, atopic dermatitis and toxic epidermal necrolysis.

MiRNAs are present not only in the intracellular space, but also in extracellular spaces such as serum, urine, and saliva. This study is the first to evaluate microRNA in serum of acne vulgaris patients.

Study Type

Observational

Enrollment (Estimated)

120

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

Sampling Method

Non-Probability Sample

Study Population

the study will include patients with active acne vulgaris ( mild, moderate, severe) who will come to the out-patient dermatologic clinic and match inclusion & exclusion criteria

Description

Inclusion Criteria:

  • 1. Healthy persons of both sexes with mild, moderate and severe acne vulgaris.
  • 2. Patients with acne vulgaris not receiving any topical or systemic treatments for acne at least 6 months

Exclusion Criteria:

  • 1. Pregnant and lactating women
  • 2. Patients with history of cardiovascular disorder, renal disease, malignancy, chronic liver disease
  • 3. Patients with history of depression or mental illness
  • 4. Diabetes type 2
  • 5. Obesity
  • 6. Patient with history of melasma, psoriasis, eczema, atopic dermatitis and toxic epidermal necrolysis.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
mild form of acne vulgaris
Other: measure serum MicroRNA in acne vulgaris
Quantitively assay of serum microRNA level will be measured control by performing an enzyme-linked immune sorbent assay (E LISA)
group2
moderate form of acne vulgaris
Other: measure serum MicroRNA in acne vulgaris
Quantitively assay of serum microRNA level will be measured control by performing an enzyme-linked immune sorbent assay (E LISA)
group 3
severe form of acne vulgaris
Other: measure serum MicroRNA in acne vulgaris
Quantitively assay of serum microRNA level will be measured control by performing an enzyme-linked immune sorbent assay (E LISA)
group 4
control group
Other: measure serum MicroRNA in acne vulgaris
Quantitively assay of serum microRNA level will be measured control by performing an enzyme-linked immune sorbent assay (E LISA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate serum levels of microRNA in acne vulgaris patients
Time Frame: baseline
Evaluate serum levels of microRNA in acne vulgaris patients and compare with levels in healthy controls and determine correlation with acne severity
baseline

Collaborators and Investigators

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

Sponsor

South Valley University

Investigators

  • Study Director: Hassan Mohammed Ibrahim, professor, South Valley University
  • Study Director: Abdulrahman Abdul Hamid Alsaied, 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)

August 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • serum microRNA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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