A study for evaluation of sexual function in Thai patients with moderate to severe acne vulgaris receiving low-dose isotretinoi

• Conditions: Isotretinoin; Acne vulgaris; Sexual function; Erectile dysfunction; Moderate-to-severe acne vulgaris receiving isotretinoin or doxycycline.; Adverse events

• Registration Number: TCTR20240802006
• Lead Sponsor: Chanat Kumtornrut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-02
• Last Update Posted: 19 August 2024
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

1. Males and females aged 18-50 years, sexually active.
2. Diagnosed with moderate-to-severe acne vulgaris.
3. Receiving low-dose isotretinoin (0.1-0.4 mg/kg/day or a fixed dose of 10 mg/day) or doxycycline 200 mg/day within the past week.
4. Understanding the Thai language.
5. Written informed consent.

Exclusion Criteria

1. Severe medical conditions.
2. History of psychiatric disorders.
3. High risk of depression defined by PHQ-9 scores equal to or greater than 7.
4. Concomitant diseases affecting acne severity and sexual function, e.g., PCOS.
5. Current use of oral contraceptives or anti-androgenic medication.
6. History of isotretinoin use within the past 6 months.
7. Breastfeeding or pregnancy.
8. Postmenopausal women.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arizona Sexual Experience Scale (ASEX) 0, 3-4 months Self-questionnaires for evaluating sexual function (for male patients) reported as scores (range 5-30),The International Index of Erectile Function (IIEF-5) 0, 3-4 months Self-questionnaires for evaluating sexual function (for male patients) reported as scores (range 5-25),Female Sexual Function Index (FSFI) 0, 3-4 months Self-questionnaires for evaluating sexual function (for female patients) reported as scores (range 2-36)

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire, PHQ-9 0, 3-4 months Self-questionnaire to screen patients with high risk of depression (scores more than 7),Dermatology Life Quality Index, DLQI 0, 3-4 months Self-questionnaire for evaluating quality of life reported as scores (range 0-30),Personal informations (Age, BMI, marital status, partner sex, frequency of sexual intercourse, income, occupation, educational level, underlying diseases, current medications, alcohol use, smoking) Baseline Demographic data reported as mean and standard deviation (for numerical data) or frequency and percentage (for categorical data)