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

ConditionAcne Vulgaris
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorBiruni University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged ≥18 years.

Clinical diagnosis of moderate to severe acne vulgaris.

Planned initiation of systemic isotretinoin therapy.

Ability to provide informed consent

Disqualifiers

Use of hormonal therapy (oral contraceptives, antiandrogens, systemic corticosteroids) within the last 3 months.

Contraindications to isotretinoin therapy.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

64 Participants
are grouped into 2 trial groups
Group A: High DHEAS, FSH, LH
Group B: Normal DHEAS, FSH, LH

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.