Measurement of Serum microRNA in Acne Vulgaris Patient

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05885217
• Other study ID #: serum microRNA
• Status: Not yet recruiting
• Start date: August 2023
• Est. completion date: October 2024

Study information

• Verified date: June 2023
• Source: South Valley University
• Contact: Alshayma Gamal Fouad, doctor
• Phone: 01065034422
• Email: shaymagamal1995[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

References & Publications (6)

Borgia F, Peterle L, Custurone P, Vaccaro M, Pioggia G, Gangemi S. MicroRNA Cross-Involvement in Acne Vulgaris and Hidradenitis Suppurativa: A Literature Review. Int J Mol Sci. 2022 Mar 17;23(6):3241. doi: 10.3390/ijms23063241. — View Citation

Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232. — View Citation

Goulden V, McGeown CH, Cunliffe WJ. The familial risk of adult acne: a comparison between first-degree relatives of affected and unaffected individuals. Br J Dermatol. 1999 Aug;141(2):297-300. doi: 10.1046/j.1365-2133.1999.02979.x. — View Citation

Hazarika N. Acne vulgaris: new evidence in pathogenesis and future modalities of treatment. J Dermatolog Treat. 2021 May;32(3):277-285. doi: 10.1080/09546634.2019.1654075. Epub 2019 Aug 29. — View Citation

Kellett SC, Gawkrodger DJ. The psychological and emotional impact of acne and the effect of treatment with isotretinoin. Br J Dermatol. 1999 Feb;140(2):273-82. doi: 10.1046/j.1365-2133.1999.02662.x. — View Citation

Tayel K, Attia M, Agamia N, Fadl N. Acne vulgaris: prevalence, severity, and impact on quality of life and self-esteem among Egyptian adolescents. J Egypt Public Health Assoc. 2020 Nov 5;95(1):30. doi: 10.1186/s42506-020-00056-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate serum levels of microRNA in acne vulgaris patients	Evaluate serum levels of microRNA in acne vulgaris patients and compare with levels in healthy controls and determine correlation with acne severity	baseline

External Links

•   Mstfa S A G. An Overview About Acne Vulgaris. Journal of Pharmaceutical Negative Results.(2022):4395-4402
•   U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER).Guidance for industry. Acne vulgaris: developing drugs for treatment.(2005).