ClinicalTrials.gg
RecruitingNCT07818525Updated Sep 14, 2026

The Impact of Baseline Hormonal Profiles (DHEAS, FSH, LH) on Treatment Response to Systemic Isotretinoin in Adult Female Patients With Acne Vulgaris

An observational study in Acne Vulgaris, sponsored by Biruni University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Biruni University · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
64
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

Acne vulgaris is a common dermatological condition in adult women, often influenced by hormonal factors. Androgens such as dehydroepiandrosterone sulfate (DHEAS) can stimulate sebaceous gland activity, while gonadotropins (FSH and LH) reflect ovarian and hypothalamic-pituitary axis function. Although systemic isotretinoin is highly effective in severe or treatment-resistant acne, variability in treatment response has been observed among female patients. The role of baseline hormonal levels in predicting isotretinoin response remains unclear. Identifying hormonal predictors of treatment response may improve patient stratification and personalized management. Aim of the study is to evaluate whether baseline serum levels of DHEAS, FSH, and LH are associated with clinical response to systemic isotretinoin in women aged 18 years and older with acne vulgaris.

02

Conditions studied

  • Acne Vulgaris

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Keywords

  • acne vulgaris
  • isotretinoin
  • androgen
  • hormone
03

In context

Acne Vulgaris

790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.

This study's planned enrollment of 64 is below the median of 88 across 95 observational studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Biruni University is the lead sponsor of 180 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female patients aged ≥18 years.
  • Clinical diagnosis of moderate to severe acne vulgaris.
  • Planned initiation of systemic isotretinoin therapy.
  • Ability to provide

Exclusion criteria

Exclusion Criteria:

  • Use of hormonal therapy (oral , antiandrogens, systemic ) within the last 3 months.
  • to isotretinoin therapy.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
64 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • High DHEAS, FSH, LH

    patients with elevated levels of hormones

  • Normal DHEAS, FSH, LH

    patients with normal levels of hormones

06

What researchers measure

Primary outcomes

  1. treatment response of patients with normal and elevated levels of hormone

    The number of months and doses during which no new acne breakouts occur after starting isotretinoin treatment will be recorded.

    Time frame: from enrollment to the end of treatment at 6 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.

Of 37 observational studies under Acne Vulgaris, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 13. This study's planned 11 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2026
First posted
Sep 14, 2026
StartActual
Jan 27, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Mar 2027
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07818525
Lead sponsor
Biruni University
Responsible party
Sponsor
First posted
Sep 14, 2026
Start date
Jan 27, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Ömer Mert, Specialist Dermatologist MD
Contact
omermert95@gmail.com
+905396778884

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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