NCT05471388

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 18, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

July 20, 2022

Last Update Submit

July 20, 2022

Conditions

Keywords

Asprosin

Outcome Measures

Primary Outcomes (1)

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

    Assess serum asprosin level in male patients with acne vulgaris.

    6 months

Study Arms (2)

case

ACTIVE COMPARATOR
Diagnostic Test: serum asprosin

control

ACTIVE COMPARATOR
Diagnostic Test: serum asprosin

Interventions

serum asprosinDIAGNOSTIC_TEST

assessment of serum asprosin by a commercially available double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit.

casecontrol

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmales
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 29440921BACKGROUND
  • 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.

    PMID: 33260746BACKGROUND
  • 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.

    PMID: 26720707BACKGROUND
  • 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.

    PMID: 33747078BACKGROUND

MeSH Terms

Conditions

Acne VulgarisArachnodactyly

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesLimb Deformities, CongenitalMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Esraa A Hamoda, resident

CONTACT

Soha H Aboeldahab, assisstant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at Dematology, Venereology and Andrology department at Sohag University Hospital

Study Record Dates

First Submitted

July 20, 2022

First Posted

July 22, 2022

Study Start

July 18, 2022

Primary Completion

January 18, 2023

Study Completion

January 18, 2023

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Locations