Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea

NCT ID: NCT05045469

Last Updated: 2025-04-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-04

Study Completion Date

2024-08-04

Brief Summary

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The aim of this study is to investigate the effects of topical herbal medicine in the patients with rosacea.

Detailed Description

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Rosacea is a chronic inflammatory disorder which affects the cheek, nose, chin, forehead and eyes. It is typically characterized by cutaneous signs such as flushing, erythema, telangiectasia, papules, and pustules in the face. The pathogenic mechanism of rosacea is unknown, and there is no cure for rosacea. The therapeutic approaches include oral medicine, topical medicine and surgical interventions depending on the different subtypes of rosacea. The recent study demonstrates that combination therapy may be more effectively improved the symptoms of rosacea. Dian dao san is a topical herbal compound for reducing the features as flushing, erythema, papules, and pustules for years. The investigators hypothesize that dian dao san can be more beneficial in treating the patients with rosacea and improving the quality of life.

Conditions

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Rosacea Chinese Herbal Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group A (dian dao san group)

Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.

Group Type ACTIVE_COMPARATOR

dian dao san

Intervention Type DRUG

dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks

group B( topical medicine without therapeutic effects)

Placebo (topical medicine without therapeutic effects) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.

Group Type PLACEBO_COMPARATOR

dian dao san

Intervention Type DRUG

dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks

Interventions

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dian dao san

dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Willing to sign inform consent
* Aged above 20 years old with rosacea
* No treatment for rosacea within 2 weeks

Exclusion Criteria

* With malignant lesion in the rosacea lesion
* Rosacea lesion with high risk of infection
* Allergy to Chinese herbal medicine patch or ointment
* Pregnancy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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YUAN-CHIEH YEH, Doctor

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Keelung Chang Gung Memorial Hospital

Keelung, , Taiwan

Site Status

Countries

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Taiwan

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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202101000A3

Identifier Type: -

Identifier Source: org_study_id

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