Assessment of Serum Asprosin Level in Male Patients With... | NCT05471388

Studies
Assessment of Serum Asprosin Level in Male Patients With Acne Vulgaris

NCT05471388

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Jul 22, 2022Actual

Enrollment

72Estimated

Phase

Not Applicable

Conditions

Acne Vulgaris

Interventions

serum asprosin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 18, 2022Estimated

Primary Completion Date

Jan 18, 2023Estimated

Completion Date

Jan 18, 2023Estimated

First Submitted Date

Jul 20, 2022

First Submission Date that Met QC Criteria

Jul 20, 2022

First Posted Date

Jul 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2022

Last Update Posted Date

Jul 22, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Esraa Abdel-Azeem Hamoda, resident doctor at Dematology, Venereology and Andrology department at Sohag University Hospital, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
case	Active Comparator		Diagnostic Test: serum asprosin
control	Active Comparator		Diagnostic Test: serum asprosin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
serum asprosin	Diagnostic Test	assessment of serum asprosin by a commercially available double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit.	case

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess serum asprosin level in male patients with acne vulgaris.	Assess serum asprosin level in male patients with acne vulgaris.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

males

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Esraa A Hamoda, resident	Contact	01007911703		esraaabdelazeem@med.sohag.edu.eg
Soha H Aboeldahab, assisstant professor	Contact	01094235561

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University Hospital		Sohag			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29440921	Background	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.
33260746	Background	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.

Type	Date	Date Unknown
Release	Jan 1, 2024
Reset	Jun 21, 2024

ID	Term
D000152	Acne Vulgaris
D054119	Arachnodactyly

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases