Acne VulgarisNCT07818525
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 of Acne Vulgaris, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Acne Vulgaris
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2026to Mar 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients aged 18-40 with moderate to severe acne vulgaris who are planned to recieve isotretinoin treatment.
Who may be able to join
- Female patients aged ≥18 years.
- Clinical diagnosis of moderate to severe acne vulgaris.
- Planned initiation of systemic isotretinoin therapy.
- Ability to provide informed consent
Who cannot join
- Use of hormonal therapy (oral contraceptives, antiandrogens, systemic corticosteroids) within the last 3 months.
- Contraindications to isotretinoin therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Biruni University Hospital
Küçükçekmece, Istanbul
Ömer Mert, 05396778884, omermert95@gmail.com
About this study
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.
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris, isotretinoin, androgen, hormone
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High DHEAS, FSH, LH | patients with elevated levels of hormones | |
| Normal DHEAS, FSH, LH | patients with normal levels of hormones |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start27 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818525
- Sponsor's protocol ID
- Acne Dheas
- Status last verified
- Mar 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Baseline Hormonal Profiles (DHEAS, FSH, LH) on Treatment Response to Systemic Isotretinoin in Adult Female Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07818525
- Acronym / sponsor ID
- Acne Dheas
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris, isotretinoin, androgen, hormone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High DHEAS, FSH, LH | – | –patients with elevated levels of hormones |
| Normal DHEAS, FSH, LH | – | –patients with normal levels of hormones |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients aged 18-40 with moderate to severe acne vulgaris who are planned to recieve isotretinoin treatment.
Key inclusion criteria (4 listed)
- Female patients aged ≥18 years.
- Clinical diagnosis of moderate to severe acne vulgaris.
- Planned initiation of systemic isotretinoin therapy.
- Ability to provide informed consent
Key exclusion criteria (2 listed)
- Use of hormonal therapy (oral contraceptives, antiandrogens, systemic corticosteroids) within the last 3 months.
- Contraindications to isotretinoin therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
treatment response of patients with normal and elevated levels of hormone
Time frame: from enrollment to the end of treatment at 6 months
The number of months and doses during which no new acne breakouts occur after starting isotretinoin treatment will be recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ömer Mert, Specialist Dermatologist MD (+905396778884, omermert95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment response of patients with normal and elevated levels of hormone (time frame: from enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.