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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Biruni University Hospital

Küçükçekmece, Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ömer Mert

CONTACT

[email protected]

05396778884

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ömer Mert, Specialist Dermatologist MD

CONTACT

[email protected]

+905396778884

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Sep 14, 2026
Registry last updated: Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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