NCT05885217

Brief Summary

The aim of the study is to:

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

May 23, 2023

Last Update Submit

July 2, 2023

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

group 1

mild form of acne vulgaris

Other: measure serum MicroRNA in acne vulgaris

group2

moderate form of acne vulgaris

Other: measure serum MicroRNA in acne vulgaris

group 3

severe form of acne vulgaris

Other: measure serum MicroRNA in acne vulgaris

group 4

control group

Other: measure serum MicroRNA in acne vulgaris

Interventions

measure serum MicroRNA in acne vulgarisOTHER

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

group 1group 3group 4group2

Eligibility Criteria

Age10 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 31393195BACKGROUND

  • 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.

    PMID: 10233222BACKGROUND

  • 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.

    PMID: 33165744BACKGROUND

  • 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.

    PMID: 10468803BACKGROUND

  • 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.

    PMID: 35328662BACKGROUND

  • 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.

    PMID: 24049221BACKGROUND

Related Links

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Hassan Mohammed Ibrahim, professor

    South Valley University

    STUDY DIRECTOR

  • Abdulrahman Abdul Hamid Alsaied, professor

    South Valley University

    STUDY DIRECTOR

Central Study Contacts

Alshayma Gamal Fouad, doctor

CONTACT

01065034422shaymagamal1995@gmail.com

soher Abdelhamid Ali, Lecturer

CONTACT

01066877343soher.abdel-hamid@med.svu.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 1, 2023

Study Start

August 1, 2023

Primary Completion

April 1, 2024

Study Completion

October 1, 2024

Last Updated

July 5, 2023

Record last verified: 2023-06