Back to resultsEvaluation of the Role of Latent Toxoplasmosis in Female Patients With Active Acne Vulgaris
Primary Purpose
Acne Vulgaris, Toxoplasmosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Free testosterone levels and toxoplasma igG
Sponsored by
About this trial
This is an interventional diagnostic trial for Acne Vulgaris
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Toxoplasmosis seropositive female patients with active acne vulgaris
Toxoplasmosis seronegative in female patients with active acne vulgaris
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05783778
Brief Title
Evaluation of the Role of Latent Toxoplasmosis in Female Patients With Active Acne Vulgaris
Official Title
Evaluation of the Role of Latent Toxoplasmosis in Female Patients With Active Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris, Toxoplasmosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Toxoplasmosis seropositive female patients with active acne vulgaris
Arm Type
Experimental
Arm Title
Toxoplasmosis seronegative in female patients with active acne vulgaris
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Free testosterone levels and toxoplasma igG
Intervention Description
Free testosterone levels and toxoplasma igG in serum by ELISA
Primary Outcome Measure Information:
Title
Measuring Toxoplasma igG and free testosterone in acne vulgaris patients and controls
Description
Detect if the toxoplasma latent infection can be associated with disease severity and hormonal disturbances in acne vulgaris female patients
Time Frame
One month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wafaa Mohamed Abdel Mageed
Phone
01008813349
Email
Wafaaderm78@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rasha Ismail Mohamed
Phone
01006592879
Email
r.alkady21@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of the Role of Latent Toxoplasmosis in Female Patients With Active Acne Vulgaris
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