Acne VulgarisNCT05885217
Measurement of Serum microRNA in Acne Vulgaris Patient
An observational study of Acne Vulgaris, run by South Valley University.
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 Read more about this study
- Who is it for?
- Ages 10 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- measure serum MicroRNA in acne vulgaris
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Serum MicroRNA in Acne Vulgaris and Relation to Acne Severity
The aim of the study is to:
- Evaluation of serum microRNA in acne vulgaris and compare to control group
- Evaluate correlation with acne vulgaris severity
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- measure serum MicroRNA in acne vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| group 1 | mild form of acne vulgaris Receives: Other: measure serum MicroRNA in acne vulgaris | |
| group2 | moderate form of acne vulgaris Receives: Other: measure serum MicroRNA in acne vulgaris | |
| group 3 | severe form of acne vulgaris Receives: Other: measure serum MicroRNA in acne vulgaris | |
| group 4 | control group Receives: Other: measure serum MicroRNA in acne vulgaris |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study startAug 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshayma Gamal Fouad, South Valley University
- Investigators
- Hassan Mohammed Ibrahim, professor, Study director, South Valley UniversityAbdulrahman Abdul Hamid Alsaied, professor, Study director, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885217
- Sponsor's protocol ID
- serum microRNA
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31393195Kellett 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.
PubMed 10233222Tayel 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.
PubMed 33165744Goulden 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.
PubMed 10468803Borgia 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.
PubMed 35328662Charan 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.
PubMed 24049221
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum MicroRNA in Acne Vulgaris and Relation to Acne Severity
- ClinicalTrials.gov ID
- NCT05885217
- Acronym / sponsor ID
- serum microRNA
- Conditions
- Acne Vulgaris
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to:
- Evaluation of serum microRNA in acne vulgaris and compare to control group
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: measure serum MicroRNA in acne vulgarismild form of acne vulgaris |
| group2 | – | Other: measure serum MicroRNA in acne vulgarismoderate form of acne vulgaris |
| group 3 | – | Other: measure serum MicroRNA in acne vulgarissevere form of acne vulgaris |
| group 4 | – | Other: measure serum MicroRNA in acne vulgariscontrol group |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measure serum MicroRNA in acne vulgarisQuantitively assay of serum microRNA level will be measured control by performing an enzyme-linked immune sorbent assay (E LISA) | Other | group 1, group 3, group 4, group2 |
Primary outcome
Evaluate serum levels of microRNA in acne vulgaris patients
Time frame: baseline
Evaluate serum levels of microRNA in acne vulgaris patients and compare with levels in healthy controls and determine correlation with acne severity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Background: PubMed 31393195Hazarika 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.
- Background: PubMed 10233222Kellett 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.
- Background: PubMed 33165744Tayel 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.
- Background: PubMed 10468803Goulden 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.
- Background: PubMed 35328662Borgia 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.
- Background: PubMed 24049221Charan 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.
- Mstfa S A G. An Overview About Acne Vulgaris. Journal of Pharmaceutical Negative Results.(2022):4395-4402Link provided by the sponsor.
- 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).Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Mohammed Ibrahim, professor study director
South Valley University
Abdulrahman Abdul Hamid Alsaied, professor study director
South Valley University
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by South Valley University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alshayma Gamal Fouad, doctor (01065034422, shaymagamal1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate serum levels of microRNA in acne vulgaris patients (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05885217, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.