Hormonal profiles and isotretinoin response in adult women with acne
Official title: The Impact of Baseline Hormonal Profiles (DHEAS, FSH, LH) on Treatment Response to Systemic Isotretinoin in Adult Female Patients With Acne Vulgaris
Run by Biruni University · NCT07818525 · Data updated 2026-11-12
This study tests whether baseline hormones (DHEAS, FSH, and LH) help predict how adult women with acne will respond to systemic isotretinoin.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 64 (estimated) |
| Sponsor | Biruni University Academic / other |
| Locations | 1 site (Küçükçekmece, Istanbul) |
| Status | Recruiting |
| Started | January 27, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | March 2027 |
| Registry record updated | September 14, 2026 |
| Trial ID | NCT07818525 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women (≥18) with moderate to severe acne vulgaris planning systemic isotretinoin and not on hormonal therapy in the last 3 months.
✕Probably not a fit
Patients with acne driven by factors unrelated to the measured hormones or who have non-hormonal determinants of response may not see predictive benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study explores whether initial blood levels of DHEAS, FSH, and LH are associated with clinical response to systemic isotretinoin in women aged 18 and older with moderate to severe acne vulgaris. Participants are adult women planning isotretinoin therapy and not currently on hormonal treatments. The research examines baseline hormone measurements to identify potential predictors of treatment outcome in a real-world setting. It is conducted at Biruni University Hospital in Istanbul and does not specify an intervention beyond routine isotretinoin treatment. Results could inform future patient stratification and personalized management approaches.
Why it matters
Potential benefit: If predictors are identified, clinicians could tailor isotretinoin decisions and monitoring based on a patient’s hormonal profile.
How similar studies have gone: Prior work has shown that hormonal factors can influence acne and isotretinoin response, but direct predictive value of baseline DHEAS, FSH, and LH in this context is not well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients aged ≥18 years. * Clinical diagnosis of moderate to severe acne vulgaris. * Planned initiation of systemic isotretinoin therapy. * Ability to provide informed consent Exclusion Criteria: * Use of hormonal therapy (oral contraceptives, antiandrogens, systemic corticosteroids) within the last 3 months. * Contraindications to isotretinoin therapy.
Where it's running
-
Biruni University Hospital
Küçükçekmece, Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Ömer Mert, Specialist Dermatologist MD
- Email: omermert95@gmail.com
- Phone: +905396778884
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.