Herbal Ointment in Treating Atopic Dermatitis Topically

Last updated: February 23, 2025
Sponsor: En Chu Kong Hospital
Overall Status: Active - Recruiting

Phase

2/3

Condition

Eczema (Atopic Dermatitis)

Dermatitis, Atopic

Allergy

Treatment

Placebo

herbal ointment

Clinical Study ID

NCT06850311
ECKIRB1130403
  • Ages 18-65
  • All Genders

Study Summary

Atopic dermatitis (AD), also known as atopic eczema, is a chronic inflammatory skin disorder. The current first-line recommended treatment for AD is the use of emollients, topical corticosteroids (TCS), and oral antihistamines if necessary. However, patients often have side effects like skin atrophy and telangiectasia. And there were plenty of herbal medicine which are beneficial to atopic dermatitis in ancient Chinese medicine books and records. Therefore, the purpose of this study is to develop a new topical application of traditional Chinese medicine and evaluate its clinical efficacy in AD patients. In human trial, 66 Subjects diagnosed as AD will be enrolled and treated with Sophora flavescens Aiton topical ointment. After treatment we will estimate the efficacy and record adverse events to conduct statistically analysis.

The 1st year project: (1) Expect to enroll 66 clinical subjects of AD. (2) Evaluate subjects 'symptom and proceed herbal ointment treatment. (3) Record treatment responses including adverse effect. (4) Conduct statistically analysis.

The 2nd year project: (1) Completing enrollment of 66 clinical subjects of AD. (2) Finish evaluation and treatment of all subjects. (3) Statistically analysis all collecting data (4) Discuss and analyze the outcome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Between 18 and 65 years old, female or male.

  2. Atopic dermatitis fulfilling the diagnostic criteria of Hanifin&Rajka.

  3. Atopic dermatitis involving <10% of BSA. (Base on the BSA result of Screening)

  4. An Investigator's Global Assessment (IGA) score of 2, 3 or 4 which corresponds tomild, moderate or severe disease. (Base on the IGA result of Screening)

  5. Female patients of child-bearing age with negative pregnancy test at screening.

  6. Female patients of child-bearing age that agree to continue using birth controlmeasures approved by the investigator and agree not to lactate for the duration ofthe study.

Agree to only receive stable doses of an additive-free, basic bland emollient for at least 7 days before baseline (day0) Willing to comply with study protocol and agree to sign an informed consent form.

Exclusion

Exclusion Criteria:

  1. Having a history of topical or systematical hypersensitivity to herbal or itsexcipient (e.g. vehicle) in ointment

  2. Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressiveagents) within 30 days.

  3. Having used topical or oral therapy (e.g. topical corticosteroids, antibiotic, TCM)for dermatitis within 7 days before the first application of the study medication.

  4. Having a significant concurrent disease, such as: significant abnormalities inhematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetesmellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer orAIDS.

  5. Having abnormal liver or renal function (AST/ALT >3 x ULN, creatinine >2.0 mg/dl).

  6. Women who are lactating, pregnant or preparing to be pregnant.

Study Design

Total Participants: 66
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
March 01, 2025
Estimated Completion Date:
April 01, 2027

Connect with a study center

  • En Chu Kong hospital

    New Taipei City, 237
    Taiwan

    Active - Recruiting

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