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A clinical study of Shibeixiaocuo Formula combined with photodynamic therapy in the treatment of moderate to severe acne

A clinical study of Shibeixiaocuo Formula combined with photodynamic therapy in the treatment of moderate to severe acne

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081685
Enrollment
Unknown
Registered
2024-03-08
Start date
2024-03-10
Completion date
Unknown
Last updated
2024-03-11

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

Conditions

Moderate to severe acne

Interventions

treatment group:Shibeixiaocuo formula+photodynamic therapy

Sponsors

Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) 14 years old= age = 50 years old; (2) Meet the clinical diagnostic criteria for moderate to severe acne; (3) Meet the TCM syndrome standards of damp-heat stasis syndrome; (4) Voluntarily take the test and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those who are allergic to the test drug (Shibeixiaocuo formula, any ingredient in photosensitizer) or alcohol; (2) Those who are taking photosensitizing drugs; (3) Porphyria or allergy to porphyrins, with a history of photosensitivity; (4) Pregnant or lactating women and those who plan to become pregnant within 3 months; (5) Oral or topical antibiotics, tretinoins, glucocorticoids, benzoyl peroxide and other drugs in the past 1 month; (6) Have a history of sun exposure in the past 1 month, have received photoelectric therapy in the past 3 months, or received facial resurfacing treatment in the past 6 months; (7) Those who are using vasodilators (such as nitroglycerin, etc.), ß receptor blockers (such as metoprolol, etc.), anticoagulants (such as warfarin, etc.) and other drugs that are easy to cause facial telangiectasia; (8) Patients with facial rosacea, atopic dermatitis, hormone-dependent dermatitis and other facial skin-related diseases; (9) Abnormal blood and urine routine, liver and kidney function, important organ lesions and hematopoietic system diseases, and other diseases that the investigator considers unsuitable for participating in clinical trials; (10) Patients who participate in other clinical trials at the same time.

Design outcomes

Primary

MeasureTime frame
Global Acne Grading System;

Secondary

MeasureTime frame
Inflammatory (papules, pustules, nodules, and cysts) and non-inflammatory (comedone) acne lesion counts;Acne-specific Quality of Life Assessment Instrument;

Countries

China

Contacts

Public ContactChi Huiyan

Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine

chihuiyan@163.com+86 62835136

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026