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Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea

Primary Purpose

Rosacea, Chinese Herbal Medicine

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
dian dao san
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keelung Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

group A (dian dao san group)

group B( topical medicine without therapeutic effects)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

reduction of flushing, erythema, telangiectasia, papules, and pustules
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).
absence of adverse skin reaction to topical medicine
scored with Dyshidrotic Eczema Area and Severity Index (DASI index). The total score of the DASI results from the sum of severity grade score points of each of the four items (V = vesicles, E = erythema, S = desquamation, I = itch) multiplied by the affected area (A) score points: DASI = (pV + pE + pS + pI) × pA. The maximum possible score is 60. By the DASI, the dyshidrotic eczema is graded as: mild (0-15), moderate (16-30) and severe (31-60).

Secondary Outcome Measures

improvement of life quality
Dermatology Quality of Life Index, DQoL is the questionnaire which designed to measure the health-related quality of life of adult patients suffering from a skin disease ranging from 0(no effect at all on patient's life) to 30(extremely large effect on patient's life).

Full Information

First Posted
September 7, 2021
Last Updated
September 15, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05045469
Brief Title
Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea
Official Title
Therapeutic Effects of Topical Herbal Medicine on Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
August 4, 2022 (Anticipated)
Study Completion Date
August 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea, Chinese Herbal Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A (dian dao san group)
Arm Type
Active Comparator
Arm Description
Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.
Arm Title
group B( topical medicine without therapeutic effects)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
dian dao san
Intervention Description
dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks
Primary Outcome Measure Information:
Title
reduction of flushing, erythema, telangiectasia, papules, and pustules
Description
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).
Time Frame
6 weeks
Title
absence of adverse skin reaction to topical medicine
Description
scored with Dyshidrotic Eczema Area and Severity Index (DASI index). The total score of the DASI results from the sum of severity grade score points of each of the four items (V = vesicles, E = erythema, S = desquamation, I = itch) multiplied by the affected area (A) score points: DASI = (pV + pE + pS + pI) × pA. The maximum possible score is 60. By the DASI, the dyshidrotic eczema is graded as: mild (0-15), moderate (16-30) and severe (31-60).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
improvement of life quality
Description
Dermatology Quality of Life Index, DQoL is the questionnaire which designed to measure the health-related quality of life of adult patients suffering from a skin disease ranging from 0(no effect at all on patient's life) to 30(extremely large effect on patient's life).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YUAN-CHIEH YEH, Doctor
Phone
24313131
Ext
2127
Email
b9005030@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
HUAN-HSUAN HSU, Doctor
Phone
24313131
Ext
2127
Email
emilyhsu224@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YUAN-CHIEH YEH, Doctor
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keelung Chang Gung Memorial Hospital
City
Keelung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YUAN-CHIEH YEH

12. IPD Sharing Statement

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Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea

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