NCT06149065

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
247

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

November 20, 2023

Last Update Submit

November 27, 2023

Conditions

Keywords

Diet, Female-to-male transgender, Masculinizing hormone therapy, Risk factors

Outcome Measures

Primary Outcomes (1)

  • The severity of acne

    Investigator Global Assessment (IGA) scale for acne

    1 day (At the time of answering an online questionnaire)

Interventions

Masculinizing hormone therapy (testosterone) is used in female-to-male transgenders for medical reason.

Also known as: Demographic data, acne-related clinical risk factors

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsTransgender male (also: trans man, female-to-male, transgender male): this refers to individuals assigned female at birth but who identify and live as men.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All transmen who visited the Gender Variation (GenV) Clinic (outpatient clinic) of Ramathibodi Hospital

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to participate
  • Incomplete questionnaire
  • Missing photos
  • Diagnosis of any disorders of sexual differentiation which may have peculiar hormonal effect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Acne VulgarisTranssexualism

Interventions

TestosteroneDemography

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesSexualitySexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
17 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 28, 2023

Study Start

June 5, 2021

Primary Completion

June 6, 2023

Study Completion

June 6, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations