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

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06149065
• Collaborator: (none)
• Enrollment: 247
• Location: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 10.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne; Transgenderism	Drug: Testosterone

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 247 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Factors Associated With the Acne Severity Among Transmen Population: a Cross-sectional Study
• Actual Study Start Date: Jun 5, 2021
• Actual Primary Completion Date: Jun 6, 2023
• Actual Study Completion Date: Jun 6, 2023

Outcome Measures

Primary Outcome Measures

1. The severity of acne [1 day (At the time of answering an online questionnaire)]

   Investigator Global Assessment (IGA) scale for acne

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University	Ratchathewi	Bangkok	Thailand	10400

Sponsors and Collaborators

• Mahidol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT06149065
• Other Study ID Numbers: 2124
• First Posted: Nov 28, 2023
• Last Update Posted: Nov 28, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mahidol University: Diet, Female-to-male transgender, Masculinizing hormone therapy, Risk factors
• Additional relevant MeSH terms: Acne Vulgaris; Testosterone

Study Results

No Results Posted as of Nov 28, 2023