Evaluation of the Role of Latent Toxoplasmosis in Female Patients With Active Acne Vulgaris

March 13, 2023 updated by: Zineb Gamee Aly Ahmed, Sohag University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

One of the hidden hormonal imbalance is Toxoplasma infection.Toxoplasmosis is a zoonotic infection the definite host is feline whereas human and other warm blooded animals are intermediate host . Endocrine alterations occuring during toxoplasmosis can be a hidden cause of acne vulgaris

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- Female patients with active acne vulgaris

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toxoplasmosis seropositive female patients with active acne vulgaris
Diagnostic test: Free testosterone levels and toxoplasma igG
Free testosterone levels and toxoplasma igG in serum by ELISA
Experimental: Toxoplasmosis seronegative in female patients with active acne vulgaris
Diagnostic test: Free testosterone levels and toxoplasma igG
Free testosterone levels and toxoplasma igG in serum by ELISA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring Toxoplasma igG and free testosterone in acne vulgaris patients and controls
Time Frame: One month
Detect if the toxoplasma latent infection can be associated with disease severity and hormonal disturbances in acne vulgaris female patients
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-03-05MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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