NCT05045469

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2024

Completed
8 months until next milestone

Results Posted

Study results publicly available

April 1, 2025

Completed
Last Updated

April 1, 2025

Status Verified

January 1, 2024

Enrollment Period

2.8 years

First QC Date

September 7, 2021

Results QC Date

February 16, 2025

Last Update Submit

March 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 weeks

Secondary Outcomes (1)

  • Dermatology Quality of Life Index, DQoL

    6 weeks

Study Arms (2)

group A (dian dao san group)

ACTIVE COMPARATOR

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

Drug: dian dao san

group B( topical medicine without therapeutic effects)

PLACEBO COMPARATOR

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.

Drug: dian dao san

Interventions

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

group A (dian dao san group)group B( topical medicine without therapeutic effects)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. HuanHsuan Hsu
Organization
CGMH

Study Officials

  • YUAN-CHIEH YEH, Doctor

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 16, 2021

Study Start

August 4, 2021

Primary Completion

May 23, 2024

Study Completion

August 4, 2024

Last Updated

April 1, 2025

Results First Posted

April 1, 2025

Record last verified: 2024-01

Locations