NCT07277075

Brief Summary

This study aimed to assess the serum level of Leucine-rich alpha-2 glycoprotein 1 (LRG1) in Acne vulgaris (AV) individuals and evaluate the effect of probiotic therapy on these serum levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

November 29, 2025

Last Update Submit

November 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serum Leucine-Rich Alpha-2 Glycoprotein 1 Level

    Serum Leucine-Rich Alpha-2 Glycoprotein 1 Level was assessed.

    12 weeks after the therapy

Secondary Outcomes (2)

  • Acne severity

    12 weeks after the therapy

  • Patient satisfaction

    12 weeks after the therapy

Study Arms (2)

Study group

Participants with clinically diagnosed mild to moderate acne vulgaris (AV) based on the Glycosaminoglycans (GAGs).

Diagnostic Test: Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) level

Control group

Apparently healthy controls matched for age and sex

Diagnostic Test: Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) level

Interventions

Serum Leucine-rich alpha-2 glycoprotein 1 (LRG1) levels were assessed in acne vulgaris participants and healthy controls.

Control groupStudy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This case-control study was conducted on all participants enrolled from the Dermatology \& Andrology Outpatient Clinic at Benha University Hospital, Egypt, between October 2024 and September 2025.

You may qualify if:

  • Age ≥18 years.
  • Both sexes.
  • Had not used systemic or topical acne therapy for at least two months or two weeks before the research, respectively.
  • Participants with clinically diagnosed mild to moderate acne vulgaris (AV) based on the Global Acne Grading System (GAGS)

You may not qualify if:

  • Pregnancy.
  • Lactation.
  • History of hypersensitivity to probiotic components.
  • Smoking.
  • Presence of infections.
  • Autoimmune or malignant diseases.
  • Receiving any systemic therapy likely to affect the microbiome or inflammatory biomarkers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University

Banhā, Benha, 13518, Egypt

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MBBCH of Dermatology, Venereology and Andrology, Benha University, Benha, Egypt.

Study Record Dates

First Submitted

November 29, 2025

First Posted

December 11, 2025

Study Start

October 1, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

December 11, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations