RosaceaNCT07296497
Acupuncture for Refractory Rosacea: A Study on Its Effectiveness and Safety
A study testing Acupuncture in people with Rosacea, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This study is a randomized, multicenter, sham-controlled clinical trial designed to evaluate the efficacy and safety of acupuncture for patients with refractory rosacea. A total of 104 participants will be enrolled and randomly assigned in a 1:1 ratio to the acupuncture group or the sham acupuncture group (52… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rosacea
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with refractory rosacea, defined as those who have received at least 12 weeks of conventional oral medication (such as doxycycline), with or without other treatments (e.g., topical medications or intense pulsed light [IPL] therapy), but remain treatment-resistant - characterized by no improvement of erythema by at least one CEA grade, persistent erythema ≥ grade 3, or recurrent flushing that affects quality of life (DLQI indicating at least a moderate impact); or patients who experience frequent relapses during the 12-week treatment period;
- Age between 18 and 65 years, inclusive, with no restriction on sex;
- Individuals who fully understand the purpose and significance of the study, voluntarily agree to participate, sign the informed consent form (ICF), and are willing to comply with all study procedures and follow-up requirements.
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
- Patients with diabetes mellitus or moderate to severe systemic diseases affecting the liver, kidney, lung, or hematologic system;
- Patients with depression or other psychiatric disorders;
- Individuals with severe abnormal reactions to acupuncture (e.g., syncope during acupuncture, allergy to acupuncture needles);
- Patients with rosacea accompanied by nasal hypertrophy or other facial dermatoses (such as seborrheic dermatitis, eczema) or facial manifestations of other systemic diseases (such as dermatomyositis, systemic lupus erythematosus);
- Individuals with a bleeding tendency or coagulation disorders, or with skin damage, infection, or other lesions at the acupuncture sites;
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- Patients who discontinued oral antibiotics less than 1 month prior to enrollment; discontinued non-antibiotic oral medications less than 15 days prior (or isotretinoin less than 3 months prior); or discontinued topical medications less than 1 week prior;
- Patients who are expected to be unable to comply with follow-up requirements;
- Individuals who have participated in any other clinical trial within 1 month before screening (defined as having signed an informed consent form and received an investigational drug/device/placebo);
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Ben Wang, 8613875885737, wangben0804@163.com
About this study
Official title: A Randomized, Multicenter, Single-blind, Sham-controlled Clinical Trial on the Efficacy and Safety of Acupuncture in the Treatment of Refractory Rosacea.
This study is a randomized, multicenter, sham-controlled clinical trial designed to evaluate the efficacy and safety of acupuncture for patients with refractory rosacea. A total of 104 participants will be enrolled and randomly assigned in a 1:1 ratio to the acupuncture group or the sham acupuncture group (52 participants in each group, regardless of sex). The primary aim is to determine whether acupuncture can effectively alleviate facial erythema and flushing episodes compared with sham stimulation.
Read the detailed description
Participants in the acupuncture group will receive electroacupuncture treatment using continuous waves at a frequency of 1 Hz, delivering microcurrent intensity comparable to human bioelectric levels for 20 minutes per session. Participants in the sham group will receive noninvasive stimulation with blunt-tipped needles that do not penetrate the skin. The study duration is 17 weeks in total, consisting of a 1-week baseline observation period, an 8-week treatment phase (16 treatment sessions in total), and an 8-week follow-up phase. Five in-person assessment visits will be conducted at weeks 0, 4, 8, and 12, followed by an online follow-up at week 16. The study will assess improvements in rosacea symptoms and monitor treatment safety throughout the study period.
- Conditions
- Rosacea
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- rosacea, acupuncture
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
The acupuncture sites are primarily located on the face, neck, and proximal limbs along major blood vessels. The specific acupoints include Jiquan (HT1), Yinlian (LR11), Weizhong (BL40), Chize (LU5), and facial Ashi points. The needles are inserted to a depth of 2-3 mm, retained, and stimulated with continuous waves at a frequency of 1 Hz for 20 minutes. Electrical stimulation is not applied to the facial Ashi points, where needles are retained only. The treatment course lasts for 8 weeks, with two sessions per week, for a total of 16 sessions.
Sham AcupunctureProcedure or surgery
Use blunt-tipped acupuncture needles to deliver sham stimulation. The blunt needles do not penetrate the skin. The treatment sites, needle retention time, and electrical stimulation frequency are identical to those in the acupuncture group. The treatment duration and frequency are also the same as in the acupuncture group.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group | Experimental | Not described Receives: Device: Acupuncture |
| sham acupuncture group | Sham comparator | Not described Receives: Procedure: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of successful treatment for rosacea erythema
The treatment is defined as successful when the Clinician's Erythema Assessment (CEA) score is ≤ 1 or has decreased by 2 points from baseline.
Measured: week0，4，8，12
Secondary outcomes (7)
improvement in severity of rosacea flushing
This outcome is evaluated using the Rosacea Clinical Severity Assessment Scale - Patient Version (RCSAS-P), a patient-reported questionnaire capturing daily symptom burden. Patients score subjective symptoms-including facial flushing, erythema intensity, burning/stinging sensations, warmth, and overall discomfort-on structured rating items. The scale reflects symptom severity from the patient's perspective and complements clinician assessments.
Measured: week0，4，8，12
improvement in burning sensation severity in rosacea
This outcome is evaluated using the Rosacea Clinical Severity Assessment Scale - Patient Version (RCSAS-P), a patient-reported questionnaire capturing daily symptom burden. Patients score subjective symptoms-including facial flushing, erythema intensity, burning/stinging sensations, warmth, and overall discomfort-on structured rating items. The scale reflects symptom severity from the patient's perspective and complements clinician assessments.
Measured: week0，4，8，12
improvement in degree of telangiectasia in rosacea
This outcome is evaluated using the Rosacea Clinical Severity Assessment Scale - Patient Version (RCSAS-P), a patient-reported questionnaire capturing daily symptom burden. Patients score subjective symptoms-including facial flushing, erythema intensity, burning/stinging sensations, warmth, and overall discomfort-on structured rating items. The scale reflects symptom severity from the patient's perspective and complements clinician assessments.
Measured: week0，4，8，12
Pittsburgh Sleep Quality Index (PSQI)
Measured: week0，4，8，12
Rosacea-Specific Quality of Life Questionnaire (RosQoL)
Measured: week0，4，8，12
improvement in the number/frequency of weekly flushing episodes in rosacea
This outcome is evaluated using the Rosacea Diary, a structured patient-reported daily log designed to document symptom fluctuations. Participants record the presence, frequency, and severity of flushing episodes, as well as associated erythema, burning, stinging, and discomfort. The diary captures day-to-day variability and provides quantitative data on weekly flushing patterns and symptom burden.
Measured: week0，4，8，12
Number of participants with treatment-related adverse events as assessed by the Rosacea Treatment-Related Adverse Event Recording Form (RTAERF)
Treatment-related adverse events (AEs) will be collected using the Rosacea Treatment-Related Adverse Event Recording Form (RTAERF), an investigator-developed safety assessment tool. The form captures all local and systemic AEs, including onset, duration, severity, relationship to the intervention, and outcome. AEs will be summarized as the number and proportion of participants experiencing at least one treatment-related AE during the study period. Serious adverse events (SAEs) will also be documented and reported separately.
Measured: week0，4，8，12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start24 Dec 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296497
- Sponsor's protocol ID
- 202507085-2
- Status last verified
- Oct 2025
- First submitted
- 24 Nov 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated statistical results will be shared through academic publication. Individual participant data will not be shared due to confidentiality and privacy protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Single-blind, Sham-controlled Clinical Trial on the Efficacy and Safety of Acupuncture in the Treatment of Refractory Rosacea.
- ClinicalTrials.gov ID
- NCT07296497
- Acronym / sponsor ID
- 202507085-2
- Conditions
- Rosacea
- Keywords
- rosacea, acupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, multicenter, sham-controlled clinical trial designed to evaluate the efficacy and safety of acupuncture for patients with refractory rosacea. A total of 104 participants will be enrolled and randomly assigned in a 1:1 ratio to the acupuncture group or the sham acupuncture group (52 participants in each group, regardless of sex). The primary aim is to determine whether acupuncture can effectively alleviate facial erythema and flushing episodes compared with sham stimulation.
Detailed description
Participants in the acupuncture group will receive electroacupuncture treatment using continuous waves at a frequency of 1 Hz, delivering microcurrent intensity comparable to human bioelectric levels for 20 minutes per session. Participants in the sham group will receive noninvasive stimulation with blunt-tipped needles that do not penetrate the skin. The study duration is 17 weeks in total, consisting of a 1-week baseline observation period, an 8-week treatment phase (16 treatment sessions in total), and an 8-week follow-up phase. Five in-person assessment visits will be conducted at weeks 0, 4, 8, and 12, followed by an online follow-up at week 16. The study will assess improvements in rosacea symptoms and monitor treatment safety throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture group | Experimental | Device: Acupuncture |
| sham acupuncture group | Sham comparator | Procedure: Sham Acupuncture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with refractory rosacea, defined as those who have received at least 12 weeks of conventional oral medication (such as doxycycline), with or without other treatments (e.g., topical medications or intense pulsed light [IPL] therapy), but remain treatment-resistant - characterized by no improvement of erythema by at least one CEA grade, persistent erythema ≥ grade 3, or recurrent flushing that affects quality of life (DLQI indicating at least a moderate impact); or patients who experience frequent relapses during the 12-week treatment period;
- Age between 18 and 65 years, inclusive, with no restriction on sex;
- Individuals who fully understand the purpose and significance of the study, voluntarily agree to participate, sign the informed consent form (ICF), and are willing to comply with all study procedures and follow-up requirements.
Key exclusion criteria (10 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
- Patients with diabetes mellitus or moderate to severe systemic diseases affecting the liver, kidney, lung, or hematologic system;
- Patients with depression or other psychiatric disorders;
- Individuals with severe abnormal reactions to acupuncture (e.g., syncope during acupuncture, allergy to acupuncture needles);
- Patients with rosacea accompanied by nasal hypertrophy or other facial dermatoses (such as seborrheic dermatitis, eczema) or facial manifestations of other systemic diseases (such as dermatomyositis, systemic lupus erythematosus);
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 |
|---|---|---|
| AcupunctureThe acupuncture sites are primarily located on the face, neck, and proximal limbs along major blood vessels. The specific acupoints include Jiquan (HT1), Yinlian (LR11), Weizhong (BL40), Chize (LU5), and facial Ashi points. The needles are inserted to a depth of 2-3 mm, retained, and stimulated with continuous waves at a frequency of 1 Hz for 20 minutes. Electrical stimulation is not applied to the facial Ashi points, where needles are retained only. The treatment course lasts for 8 weeks, with two sessions per week, for a total of 16 sessions. | Device | acupuncture group |
| Sham AcupunctureUse blunt-tipped acupuncture needles to deliver sham stimulation. The blunt needles do not penetrate the skin. The treatment sites, needle retention time, and electrical stimulation frequency are identical to those in the acupuncture group. The treatment duration and frequency are also the same as in the acupuncture group. | Procedure or surgery | sham acupuncture group |
Primary outcome
proportion of successful treatment for rosacea erythema
Time frame: week0，4，8，12
The treatment is defined as successful when the Clinician's Erythema Assessment (CEA) score is ≤ 1 or has decreased by 2 points from baseline.
7 secondary outcomes
improvement in severity of rosacea flushing
Time frame: week0，4，8，12
improvement in burning sensation severity in rosacea
Time frame: week0，4，8，12
improvement in degree of telangiectasia in rosacea
Time frame: week0，4，8，12
Pittsburgh Sleep Quality Index (PSQI)
Time frame: week0，4，8，12
Rosacea-Specific Quality of Life Questionnaire (RosQoL)
Time frame: week0，4，8，12
improvement in the number/frequency of weekly flushing episodes in rosacea
Time frame: week0，4，8，12
Number of participants with treatment-related adverse events as assessed by the Rosacea Treatment-Related Adverse Event Recording Form (RTAERF)
Time frame: week0，4，8，12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No. Only aggregated statistical results will be shared through academic publication. Individual participant data will not be shared due to confidentiality and privacy protection requirements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Rosacea, run by Xiangya Hospital of Central South University at 1 site in China.
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 10 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: looking for participants now, as of the sponsor's last update on 30 Jan 2026. 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ben Wang (8613875885737, wangben0804@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of successful treatment for rosacea erythema (time frame: week0，4，8，12). 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 30 Jan 2026.