RosaceaPhase 2NCT05045469
Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea
A Phase 2 study testing dian dao san in people with Rosacea and Chinese Herbal Medicine, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to investigate the effects of topical herbal medicine in the patients with rosacea. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rosacea, Chinese Herbal Medicine
- What is being tested?
- dian dao san
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Aug 2021to 4 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to sign inform consent
- Aged above 20 years old with rosacea
- No treatment for rosacea within 2 weeks
Who cannot join
- With malignant lesion in the rosacea lesion
- Rosacea lesion with high risk of infection
- Allergy to Chinese herbal medicine patch or ointment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effects of Topical Herbal Medicine on Rosacea
The aim of this study is to investigate the effects of topical herbal medicine in the patients with rosacea.
Read the 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.
- Conditions
- Rosacea, Chinese Herbal Medicine
- Being tested
- dian dao san
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dian dao sanDrug
dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: dian dao san |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (1)
Dermatology Quality of Life Index, DQoL
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start4 Aug 2021
- Primary completion23 May 2024
- Study completion4 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YUAN-CHIEH YEH, Doctor, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045469
- Sponsor's protocol ID
- 202101000A3
- Status last verified
- Jan 2024
- First submitted
- 7 Sep 2021
- Last updated
- 1 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Topical Herbal Medicine on Rosacea
- ClinicalTrials.gov ID
- NCT05045469
- Acronym / sponsor ID
- 202101000A3
- Conditions
- Rosacea, Chinese Herbal Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 4 Aug 2024 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Posted 1 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A (dian dao san group) | Active comparator | Drug: dian dao sanHerbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks. |
| group B( topical medicine without therapeutic effects) | Placebo comparator | Drug: dian dao sanPlacebo (topical medicine without therapeutic effects) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to sign inform consent
- Aged above 20 years old with rosacea
- No treatment for rosacea within 2 weeks
Key exclusion criteria (4 listed)
- With malignant lesion in the rosacea lesion
- Rosacea lesion with high risk of infection
- Allergy to Chinese herbal medicine patch or ointment
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dian dao sandian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks | Drug | group A (dian dao san group), group B( topical medicine without therapeutic effects) |
Primary outcome
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).
1 secondary outcome
Dermatology Quality of Life Index, DQoL
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YUAN-CHIEH YEH, Doctor principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dian dao san in people with Rosacea and Chinese Herbal Medicine, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.