Measurement of Serum microRNA in Acne Vulgaris Patient

Not yet recruiting

• Conditions: Acne Vulgaris
• Interventions: Other: measure serum MicroRNA in acne vulgaris

• Registration Number: NCT05885217
• Lead Sponsor: South Valley University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-05-23
• Status Verified: 2023-06
• Study First Posted: 2023-06-01
• Last Update Submitted: 2023-07-02
• Last Update Posted: 2023-07-05
• Study Start: 2023-08
• Primary Completion: 2024-04
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	measure serum MicroRNA in acne vulgaris	mild form of acne vulgaris
group 3	measure serum MicroRNA in acne vulgaris	severe form of acne vulgaris
group2	measure serum MicroRNA in acne vulgaris	moderate form of acne vulgaris
group 4	measure serum MicroRNA in acne vulgaris	control group

Primary Outcome Measures

Name	Time	Method
Evaluate serum levels of microRNA in acne vulgaris patients	baseline	Evaluate serum levels of microRNA in acne vulgaris patients and compare with levels in healthy controls and determine correlation with acne severity