Measurement of Serum microRNA in Acne Vulgaris Patient

NCT ID: NCT05885217

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-31

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Acne Vulgaris

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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group 1

mild form of acne vulgaris

measure serum MicroRNA in acne vulgaris

Intervention Type OTHER

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

measure serum MicroRNA in acne vulgaris

Intervention Type OTHER

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

measure serum MicroRNA in acne vulgaris

Intervention Type OTHER

Quantitively assay of serum microRNA level will be measured control by performing an enzyme-linked immune sorbent assay (E LISA)

group 4

control group

measure serum MicroRNA in acne vulgaris

Intervention Type OTHER

Quantitively assay of serum microRNA level will be measured control by performing an enzyme-linked immune sorbent assay (E LISA)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Alshayma Gamal Fouad

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hassan Mohammed Ibrahim, professor

Role: STUDY_DIRECTOR

South Valley University

Abdulrahman Abdul Hamid Alsaied, professor

Role: STUDY_DIRECTOR

South Valley University

Central Contacts

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Alshayma Gamal Fouad, doctor

Role: CONTACT

01065034422

soher Abdelhamid Ali, Lecturer

Role: CONTACT

01066877343

References

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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.

Reference Type BACKGROUND
PMID: 31393195 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10233222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33165744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10468803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35328662 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24049221 (View on PubMed)

Related Links

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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acne-vulgaris-establishing-effectiveness-drugs-intended-treatment

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).

Other Identifiers

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serum microRNA

Identifier Type: -

Identifier Source: org_study_id

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