AcneNCT06149065
Factors Associated With the Acne Severity Among Transmen Population: a Cross-sectional Study
An observational study of Acne and Transgenderism, run by Mahidol University at 1 site in Thailand.
Trial summary
The goal of this observational cross-sectional study is to identify factors associated with severity of acne in Thai transmen receiving masculinizing hormone therapy. The main questions it aims to answer are: What are the factors associated with severity of acne in transmen? Does masculinizing hormone therapy… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne, Transgenderism
- What is being tested?
- Testosterone
- How many people
- 247 participants
- Where
- 1 siteThailand
- Study dates
- 5 Jun 2021to 6 Jun 2023
- How long will I take part?
- 17 Months
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All transmen who visited the Gender Variation (GenV) Clinic (outpatient clinic) of Ramathibodi Hospital
Who may be able to join
- Transmen who visited the Gender Variation (GenV) Clinic of Ramathibodi Hospital
- Transmen who received masculinizing hormone therapy (testosterone)
- Transmen who completed an online questionnaire and intentional submit their facial photographs
Who cannot join
- Refusal to participate
- Incomplete questionnaire
- Missing photos
- Diagnosis of any disorders of sexual differentiation which may have peculiar hormonal effect
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, 10400
About this study
The goal of this observational cross-sectional study is to identify factors associated with severity of acne in Thai transmen receiving masculinizing hormone therapy. The main questions it aims to answer are:
- What are the factors associated with severity of acne in transmen?
- Does masculinizing hormone therapy associate with the severity of acne in transmen? Participants will be asked to complete an online questionnaire and allow to take pictures of their face for acne assessment purpose.
- Conditions
- Acne, Transgenderism
- Being tested
- Testosterone
- Keywords
- Diet, Female-to-male transgender, Masculinizing hormone therapy, Risk factors
- Medical subject headings
- Acne Vulgaris, Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Also called Demographic data, acne-related clinical risk factors
Masculinizing hormone therapy (testosterone) is used in female-to-male transgenders for medical reason.
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of acne
Investigator Global Assessment (IGA) scale for acne
Measured: 1 day (At the time of answering an online questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start5 Jun 2021
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 247 participants (actual)
- Target duration
- 17 Months
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149065
- Sponsor's protocol ID
- 2124
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 28 Nov 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 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With the Acne Severity Among Transmen Population: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06149065
- Acronym / sponsor ID
- 2124
- Conditions
- Acne, Transgenderism
- Keywords
- Diet, Female-to-male transgender, Masculinizing hormone therapy, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 28 Nov 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.
The goal of this observational cross-sectional study is to identify factors associated with severity of acne in Thai transmen receiving masculinizing hormone therapy. The main questions it aims to answer are:
- What are the factors associated with severity of acne in transmen?
- Does masculinizing hormone therapy associate with the severity of acne in transmen? Participants will be asked to complete an online questionnaire and allow to take pictures of their face for acne assessment purpose.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 17 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All transmen who visited the Gender Variation (GenV) Clinic (outpatient clinic) of Ramathibodi Hospital
Key inclusion criteria (3 listed)
- Transmen who visited the Gender Variation (GenV) Clinic of Ramathibodi Hospital
- Transmen who received masculinizing hormone therapy (testosterone)
- Transmen who completed an online questionnaire and intentional submit their facial photographs
Key exclusion criteria (4 listed)
- Refusal to participate
- Incomplete questionnaire
- Missing photos
- Diagnosis of any disorders of sexual differentiation which may have peculiar hormonal effect
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 |
|---|---|---|
| TestosteroneAlso: Demographic data, acne-related clinical risk factorsMasculinizing hormone therapy (testosterone) is used in female-to-male transgenders for medical reason. | Drug | – |
Primary outcome
The severity of acne
Time frame: 1 day (At the time of answering an online questionnaire)
Investigator Global Assessment (IGA) scale for acne
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne and Transgenderism, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of acne (time frame: 1 day (At the time of answering an online questionnaire)). 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 28 Nov 2023.