Acne VulgarisNCT05471388
Assessment of Serum Asprosin Level in Male Patients With Acne Vulgaris
A study testing serum asprosin in people with Acne Vulgaris, run by Sohag University at 1 site in Egypt.
Trial summary
Subject of interest is to evaluate serum level of asprosin in male patients with acne vulgaris, demonstrate the relation between acne vulgaris severity and level of asprosin in these patients \& the relation between metabolic syndrome in acne vulgaris and level of asprosin. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- serum asprosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jul 2022to 18 Jan 2023
- Phase
- Interventional
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Acne vulgaris male patients (>18 years) will be included.
Who cannot join
- Age <18 years.
- Females.
- Patients with other inflammatory skin disorders.
- Patients with associated systemic diseases.
- Current or previous treatment with isotretinoin in the last 3 month ,anti-inflammatory drugs, systemic antibiotics, androgen or anti androgen therapy, and steroid therapy).
- Patients known on treatment of diabetes, hypertension and dyslipidemia.
- Athletes.
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
Soha H Aboeldahab, assisstant professor contact
About this study
Subject of interest is to evaluate serum level of asprosin in male patients with acne vulgaris, demonstrate the relation between acne vulgaris severity and level of asprosin in these patients \& the relation between metabolic syndrome in acne vulgaris and level of asprosin.
- Conditions
- Acne Vulgaris
- Being tested
- serum asprosin
- Keywords
- Asprosin
- Medical subject headings
- Acne Vulgaris, Arachnodactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum asprosinDiagnostic test
assessment of serum asprosin by a commercially available double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit.
| Study group | Role | What they receive |
|---|---|---|
| case | Active comparator | Not described Receives: Diagnostic Test: serum asprosin |
| control | Active comparator | Not described Receives: Diagnostic Test: serum asprosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess serum asprosin level in male patients with acne vulgaris.
Assess serum asprosin level in male patients with acne vulgaris.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start18 Jul 2022 (estimated)
- Primary completion18 Jan 2023 (estimated)
- Study completion18 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Abdel-Azeem Hamoda, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471388
- Sponsor's protocol ID
- Soh-Med-22-07-06
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Rocha MA, Bagatin E. Adult-onset acne: prevalence, impact, and management challenges. Clin Cosmet Investig Dermatol. 2018 Feb 1;11:59-69. doi: 10.2147/CCID.S137794. eCollection 2018.
PubMed 29440921Kovacs D, Fazekas F, Olah A, Torocsik D. Adipokines in the Skin and in Dermatological Diseases. Int J Mol Sci. 2020 Nov 28;21(23):9048. doi: 10.3390/ijms21239048.
PubMed 33260746Nagpal M, De D, Handa S, Pal A, Sachdeva N. Insulin Resistance and Metabolic Syndrome in Young Men With Acne. JAMA Dermatol. 2016 Apr;152(4):399-404. doi: 10.1001/jamadermatol.2015.4499.
PubMed 26720707Hong T, Li JY, Wang YD, Qi XY, Liao ZZ, Bhadel P, Ran L, Yang J, Yan B, Liu JH, Xiao XH. High Serum Asprosin Levels Are Associated with Presence of Metabolic Syndrome. Int J Endocrinol. 2021 Mar 2;2021:6622129. doi: 10.1155/2021/6622129. eCollection 2021.
PubMed 33747078
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Serum Asprosin Level in Male Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT05471388
- Acronym / sponsor ID
- Soh-Med-22-07-06
- Conditions
- Acne Vulgaris
- Keywords
- Asprosin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 18 Jul 2022 (estimated)
- Primary completion
- 18 Jan 2023 (estimated)
- Study completion
- 18 Jan 2023 (estimated)
- First posted
- 22 Jul 2022 (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.
Subject of interest is to evaluate serum level of asprosin in male patients with acne vulgaris, demonstrate the relation between acne vulgaris severity and level of asprosin in these patients \& the relation between metabolic syndrome in acne vulgaris and level of asprosin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | Active comparator | Diagnostic Test: serum asprosin |
| control | Active comparator | Diagnostic Test: serum asprosin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acne vulgaris male patients (>18 years) will be included.
Key exclusion criteria (8 listed)
- Age <18 years.
- Females.
- Patients with other inflammatory skin disorders.
- Patients with associated systemic diseases.
- Current or previous treatment with isotretinoin in the last 3 month ,anti-inflammatory drugs, systemic antibiotics, androgen or anti androgen therapy, and steroid therapy).
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 |
|---|---|---|
| serum asprosinassessment of serum asprosin by a commercially available double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit. | Diagnostic test | case, control |
Primary outcome
Assess serum asprosin level in male patients with acne vulgaris.
Time frame: 6 months
Assess serum asprosin level in male patients with acne vulgaris.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Background: PubMed 29440921Rocha MA, Bagatin E. Adult-onset acne: prevalence, impact, and management challenges. Clin Cosmet Investig Dermatol. 2018 Feb 1;11:59-69. doi: 10.2147/CCID.S137794. eCollection 2018.
- Background: PubMed 33260746Kovacs D, Fazekas F, Olah A, Torocsik D. Adipokines in the Skin and in Dermatological Diseases. Int J Mol Sci. 2020 Nov 28;21(23):9048. doi: 10.3390/ijms21239048.
- Background: PubMed 26720707Nagpal M, De D, Handa S, Pal A, Sachdeva N. Insulin Resistance and Metabolic Syndrome in Young Men With Acne. JAMA Dermatol. 2016 Apr;152(4):399-404. doi: 10.1001/jamadermatol.2015.4499.
- Background: PubMed 33747078Hong T, Li JY, Wang YD, Qi XY, Liao ZZ, Bhadel P, Ran L, Yang J, Yan B, Liu JH, Xiao XH. High Serum Asprosin Levels Are Associated with Presence of Metabolic Syndrome. Int J Endocrinol. 2021 Mar 2;2021:6622129. doi: 10.1155/2021/6622129. eCollection 2021.
- Individual participant dataSharing planned: Yes
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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.
Soha H Aboeldahab, assisstant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serum asprosin in people with Acne Vulgaris, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 8 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 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Esraa A Hamoda, resident (01007911703, esraaabdelazeem@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess serum asprosin level in male patients with acne vulgaris. (time frame: 6 months). 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 NCT05471388, which also lists 4 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 22 Jul 2022.