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Clinical and immunological studies of isotretinoin for the treatment of acne vulgaris

Clinical and immunological studies of isotretinoin for the treatment of acne vulgaris

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119694
Enrollment
Unknown
Registered
2026-03-02
Start date
2026-03-02
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne vulgaris

Interventions

Group of mild acne:Low-dose isotretinoin <0.5 mg/kg/day
Group of moderate acne:Low-dose isotretinoin <0.5 mg/kg/day
Group of severe acne:Low-dose isotretinoin <0.5 mg/kg/day
Group A:Target cumulative dose 60 mg/kg
Group B:Target cumulative dose 90 mg/kg
Group C:Target cumulative dose 120 mg/kg

Sponsors

the First Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) Age 18–50 years, male or female; (2) Meets the diagnostic criteria for acne vulgaris and the indications for isotretinoin in the Chinese Guidelines for the Treatment of Acne (2019 Revised Edition); (3) Voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Individuals with immunodeficiency, severe systemic or organic diseases (such as heart, liver, kidney), or malignant tumors; (2) Pregnant or lactating women, or women of childbearing age who have not used effective contraception within the past month and intend to conceive within the next two years; (3) Individuals with mental symptoms, such as depression or anxiety; (4) Obese individuals (BMI >= 28 kg/m^²), those with dyslipidemia, or those with liver disease; (5) Individuals with autoimmune diseases, polycystic ovary syndrome, severe endocrine disorders, or chronic infections; (6) Individuals with severe fulminant acne or special types of acne requiring emergency intervention; (7) Individuals allergic to isotretinoin; (8) Other circumstances deemed unsuitable for participation in this trial by the researchers.

Design outcomes

Primary

MeasureTime frame
Acne lesion counting;Investigator Global Assessment;Global Acne Grading System;Dermatology Life Quality Index and satisfaction with drug treatment;

Countries

China

Contacts

Public ContactLi Zhang

Department of Dermatology, The First Hospital of China Medical University, Shenyang, China

lizhang_1001@126.com+86 139 4002 3570

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026