Acne VulgarisNCT05783778
Evaluation of the Role of Latent Toxoplasmosis in Female Patients With Active Acne Vulgaris
A study testing Free testosterone levels and toxoplasma igG in people with Acne Vulgaris and Toxoplasmosis, run by Sohag University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris, Toxoplasmosis
- What is being tested?
- Free testosterone levels and toxoplasma igG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients with active acne vulgaris
Who cannot join
- Patients with history of hormonal treatment Patients received anti toxoplasma therapy Patients with dermatological diseases caused by hormonal disturbances Pregnant and lactating patients
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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
- Conditions
- Acne Vulgaris, Toxoplasmosis
- Being tested
- Free testosterone levels and toxoplasma igG
- Medical subject headings
- Acne Vulgaris, Toxoplasmosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free testosterone levels and toxoplasma igGDiagnostic test
Free testosterone levels and toxoplasma igG in serum by ELISA
| Study group | Role | What they receive |
|---|---|---|
| Toxoplasmosis seropositive female patients with active acne vulgaris | Experimental | Not described Receives: Diagnostic Test: Free testosterone levels and toxoplasma igG |
| Toxoplasmosis seronegative in female patients with active acne vulgaris | Experimental | Not described Receives: Diagnostic Test: Free testosterone levels and toxoplasma igG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zineb Gamee Aly Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783778
- Sponsor's protocol ID
- Soh-Med-23-03-05MS
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Latent Toxoplasmosis in Female Patients With Active Acne Vulgaris
- ClinicalTrials.gov ID
- NCT05783778
- Acronym / sponsor ID
- Soh-Med-23-03-05MS
- Conditions
- Acne Vulgaris, Toxoplasmosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients with active acne vulgaris
Key exclusion criteria (1 listed)
- Patients with history of hormonal treatment Patients received anti toxoplasma therapy Patients with dermatological diseases caused by hormonal disturbances Pregnant and lactating patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free testosterone levels and toxoplasma igGFree testosterone levels and toxoplasma igG in serum by ELISA | Diagnostic test | Toxoplasmosis seronegative in female patients with active acne vulgaris, Toxoplasmosis seropositive female patients with active acne vulgaris |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Free testosterone levels and toxoplasma igG in people with Acne Vulgaris and Toxoplasmosis, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wafaa Mohamed Abdel Mageed (01008813349, Wafaaderm78@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Toxoplasma igG and free testosterone in acne vulgaris patients and controls (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.