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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20240802006
Enrollment
212
Registered
2024-08-02
Start date
2025-03-04
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate-to-severe acne vulgaris receiving isotretinoin or doxycycline. Isotretinoin

Interventions

Moderate-to-severe acne vulgaris patients receiving low-dose isotretinoin (0.1-0.4 mg/kg/day or fixed dose 10 mg/day) within 1 week at Dermatology clinic, King Chulalongkorn Memorial hospital,Moderate
Screening,Screening
Low-dose Isotretinoin,Doxycycline

Sponsors

Chanat Kumtornrut
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Thailand

Contacts

Public ContactChanat Kumtornrut

Faculty of Medicine, Chulalongkorn University

chanat_1@yahoo.com6622564253

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026