NCT05783778

Brief Summary

Acne vulgaris is one if the most common chronic inflammatory skin disorders.Acne is characterized by forming of inflammatory and non inflammatory lesions mainly on the Face,neck,arms, upper trunk and back

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

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

First Submitted

Initial submission to the registry

March 8, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 8, 2023

Last Update Submit

March 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measuring Toxoplasma igG and free testosterone in acne vulgaris patients and controls

    Detect if the toxoplasma latent infection can be associated with disease severity and hormonal disturbances in acne vulgaris female patients

    One month

Study Arms (2)

Toxoplasmosis seropositive female patients with active acne vulgaris

EXPERIMENTAL
Diagnostic Test: Free testosterone levels and toxoplasma igG

Toxoplasmosis seronegative in female patients with active acne vulgaris

EXPERIMENTAL
Diagnostic Test: Free testosterone levels and toxoplasma igG

Interventions

Free testosterone levels and toxoplasma igG in serum by ELISA

Toxoplasmosis seronegative in female patients with active acne vulgarisToxoplasmosis seropositive female patients with active acne vulgaris

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Female patients with active acne vulgaris

You may not qualify if:

  • Patients with history of hormonal treatment Patients received anti toxoplasma therapy Patients with dermatological diseases caused by hormonal disturbances Pregnant and lactating patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acne VulgarisToxoplasmosis

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesCoccidiosisProtozoan InfectionsParasitic DiseasesInfections

Central Study Contacts

Wafaa Mohamed Abdel Mageed

CONTACT

Rasha Ismail Mohamed

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zienab Gamea Ali Ahmed

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 24, 2023

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

March 24, 2023

Record last verified: 2023-03