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Assessment of Serum Asprosin Level in Male Patients With Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
serum asprosin
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acne Vulgaris focused on measuring Asprosin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Acne vulgaris male patients (>18 years) will be included.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

case

control

Arm Description

Outcomes

Primary Outcome Measures

Assess serum asprosin level in male patients with acne vulgaris.
Assess serum asprosin level in male patients with acne vulgaris.

Secondary Outcome Measures

Full Information

First Posted
July 20, 2022
Last Updated
July 20, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05471388
Brief Title
Assessment of Serum Asprosin Level in Male Patients With Acne Vulgaris
Official Title
Assessment of Serum Asprosin Level in Male Patients With Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 18, 2022 (Anticipated)
Primary Completion Date
January 18, 2023 (Anticipated)
Study Completion Date
January 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Asprosin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
case
Arm Type
Active Comparator
Arm Title
control
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
serum asprosin
Intervention Description
assessment of serum asprosin by a commercially available double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit.
Primary Outcome Measure Information:
Title
Assess serum asprosin level in male patients with acne vulgaris.
Description
Assess serum asprosin level in male patients with acne vulgaris.
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
males
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Acne vulgaris male patients (>18 years) will be included. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esraa A Hamoda, resident
Phone
01007911703
Email
esraaabdelazeem@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Soha H Aboeldahab, assisstant professor
Phone
01094235561
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R Elshrif, professor

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
29440921
Citation
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.
Results Reference
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PubMed Identifier
33260746
Citation
Kovacs 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.
Results Reference
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PubMed Identifier
26720707
Citation
Nagpal 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.
Results Reference
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PubMed Identifier
33747078
Citation
Hong 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.
Results Reference
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Assessment of Serum Asprosin Level in Male Patients With Acne Vulgaris

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