Factors Associated With the Acne Severity Among Transmen... | NCT06149065

Studies
Factors Associated With the Acne Severity Among Transmen Population: a Cross-sectional Study

NCT06149065

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Nov 28, 2023Actual

Enrollment

247Actual

Phase

Not provided

Conditions

Acne
Transgenderism

Interventions

Testosterone

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 5, 2021Actual

Primary Completion Date

Jun 6, 2023Actual

Completion Date

Jun 6, 2023Actual

First Submitted Date

Nov 20, 2023

First Submission Date that Met QC Criteria

Nov 27, 2023

First Posted Date

Nov 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2023

Last Update Posted Date

Nov 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

17 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

247Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Testosterone	Drug	Masculinizing hormone therapy (testosterone) is used in female-to-male transgenders for medical reason.		Demographic data, acne-related clinical risk factors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The severity of acne	Investigator Global Assessment (IGA) scale for acne	1 day (At the time of answering an online questionnaire)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Transgender male (also: trans man, female-to-male, transgender male): this refers to individuals assigned female at birth but who identify and live as men.

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University		Ratchathewi	Bangkok	10400	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris
D014189	Transsexualism

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013739	Testosterone
D003710	Demography

Ancestor Terms

ID	Term
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided