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Hormone tests may reveal who benefits most from acne drug

NCT ID NCT07818525

Knowledge-focused Sponsor: Biruni University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers at Biruni University are studying whether baseline blood levels of three hormones (DHEAS, FSH, and LH) are linked to how well adult women with moderate to severe acne respond to the drug isotretinoin. The trial enrolls 64 women aged 18 and older who are starting systemic isotretinoin. The team tracks how many months and doses pass without new acne breakouts, comparing women with normal versus elevated hormone levels. The goal is to learn whether hormone testing could help doctors personalize acne treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isotretinoin, a systemic acne drug
What this could lead to
If hormone levels predict who responds best, doctors could tailor acne treatment and avoid months of ineffective therapy for some women.
What could go wrong
This small observational study of 64 women can only show associations, not cause and effect. Hormone levels may turn out to have little bearing on how well isotretinoin works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Female patients aged 18-40 with moderate to severe acne vulgaris who are planned to recieve isotretinoin treatment.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acne Acne Vulgaris

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acne vulgaris

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Biruni University Hospital

    RECRUITING

    Küçükçekmece, Istanbul, Turkey (Türkiye)

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