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Completed

NCT Number: NCT05045469

Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea

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

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Key information

Conditions

Rosacea Chinese Herbal Medicine Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

dian dao san

Drug

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

Primary outcomes

  1. Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules

    Time frame: 6 weeks

    quantified by Investigator Global Assessment, IGA. IGA is used in the study for assessing the severity of rosacea ranging from 0 (clean) to 4 (most severe).

Secondary outcomes

  1. Dermatology Quality of Life Index, DQoL

    Time frame: 6 weeks

    DQoL is a questionnaire-based scale designed to measure the impact of dermatological conditions on a patient's quality of life. It assesses various aspects, including symptoms, psychological well-being, social activities, and treatment-related effects.

    Scale Range:The DQoL consists of 10 questions, each scored on a scale from 0 to 3:

    0 = Not at all, 1 = A little,2 = A lot,3 = Very much The total score ranges from 0 to 30, where higher scores indicate a greater negative impact of the skin condition on quality of life.

    Interpretation of Scale Scores:

    Total Score 0-1: No or minimal impact; 2-5: Mild impact; 6-10: Moderate impact; 11-20: Significant impact; 21-30: Severe impact Higher DQoL scores indicate worse quality of life due to the skin condition, while lower scores suggest minimal impact.

    Computation of Scores:DQoL total score is calculated as the sum of the 10 item scores.

    Unit of Measure:

    "Scores on a scale" should be used as the Unit of Measure if no other units apply.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Therapeutic Effects of Topical Herbal Medicine on Rosacea

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2021
Registry last updated
Apr 1, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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