Measurement of Serum microRNA in Acne Vulgaris Patient

Sponsor
South Valley University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05885217
Collaborator
(none)
120
13

Study Details

Study Description

Brief Summary

The aim of this study is to:
  1. Evaluation of serum microRNA in acne vulgaris and compare it to control group

  2. Evaluate correlation with acne vulgaris severity

Condition or Disease Intervention/Treatment Phase
  • Other: measure serum MicroRNA 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 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) Its 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 inflammatorymechanisms.

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 evalute microRNA in serum of acne vulgaris patients.

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Serum MicroRNA in Acne Vulgaris and Its Relation to Acne Severity
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Evaluate serum levels of microRNA in acne vulgaris patients [baseline]

    Evaluate serum levels of microRNA in acne vulgaris patients and compare them with levels in healthy controls and determine correlation with acne severity

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
    1. Healthy persons of both sexes with mild, moderate and severe acne vulgaris.
    1. Patients with acne vulgaris not receiving any topical or systemic treatments for acne at least 6 months
Exclusion Criteria:
    1. Pregnant and lactating women
    1. Patients with history of cardiovascular disorder, renal disease, malignancy, chronic liver disease
    1. Patients with history of depression or mental illness
    1. Diabetes type 2
    1. Obesity
    1. Patient with history of melasma, psoriasis, eczema, atopic dermatitis and toxic epidermal necrolysis.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • South Valley University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Alshayma Gamal Fouad, doctor, South Valley University
ClinicalTrials.gov Identifier:
NCT05885217
Other Study ID Numbers:
  • serum microRNA
First Posted:
Jun 1, 2023
Last Update Posted:
Jun 1, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2023