Plaque PsoriasisNCT03953885
Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome
A study testing Fire needle in people with Plaque Psoriasis, run by Shanghai Yueyang Integrated Medicine Hospital at 5 sites in China.
Trial summary
This study was designed as a multicenter, randomized, single blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of plaque psoriasis with blood stasis syndrome, after treated with fire needle therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Fire needle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jun 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Comply with the diagnostic criteria of Western medicine for plaque psoriasis and the diagnostic criteria for TCM syndromes;
- Skin lesions involve ≤10% BSA (the lesions are mainly located in the trunk and/or limbs, palm/sole, face/scalp, vulva area is not included);
- Age between 18 and 65 years old;
- Those who voluntarily participate in the study and sign informed consent.
Who cannot join
- Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
- Other active skin diseases may affect the condition assessment;
- Received research drugs, biological agents and immunosuppressive agents within 1 month;
- 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;
- During severe, uncontrollable local or systemic acute or chronic infections;
- Patients with severe systemic diseases; or clinical test indicators in one of the following conditions: alanine aminotransferase or aspartate aminotransferase increased by >1.5 times the upper limit of normal; creatinine increased by 1.5 times the upper limit of normal; blood routine indicators (white blood cell count) Any one of the red blood cell count, hemoglobin amount, and platelet count) is below the lower limit of normal; or other laboratory abnormalities are judged by the investigator to be unsuitable for participation in the trial;
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- A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
- Such surgery will be required during major surgery or study during 8 weeks;
- Pregnant or lactating women;
- A person with a history of alcohol abuse, drug abuse or drug abuse;
- Have a history of serious mental illness or family history;
- Other reasons researchers believe that it is inappropriate to participate in this research.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Harbin, Heilongjiang
Affiliated hospital of jiangxi university of traditional Chinese medicine
Nanchang, Jiangxi
Shanghai Yueyang Integrated Medicine Hospital
Shanghai, Shanghai Municipality
Shijiazhuang Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei
Shanxi Provincial Hospital of Traditional Chinese Medicine
Xi’an, Shanxi
About this study
Official title: Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome: A Randomized, Single-blind, Multicentre Clinical Trial
This study was designed as a multicenter, randomized, single blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of plaque psoriasis with blood stasis syndrome, after treated with fire needle therapy.
Read the detailed description
Psoriasis is a chronic inflammatory skin disease characterized by the complex interaction between the immune system, related susceptibility loci, autoantigens and various environmental factors. In China, the prevalence is about 0.47%. Current treatment strategies for psoriasis mainly focus on developing new drugs that disrupt IL-23 or IL-17 cytokine, but this targeted therapy is not effective for all patients. A growing body of evidence indicates that psoriasis-related damage is not limited to the skin, but is closely related to coronary heart disease, stroke, metabolic syndrome, and chronic kidney disease. These comorbidities have, to a certain extent, increased mortality in patients with psoriasis. Traditional Chinese medicine (TCM) has always been used to treat patients with psoriasis in China. Blood stasis syndrome is one of the basic syndromes of psoriasis. which accumulates in meridians, viscera and limbs to form a variety of syndromes with psoriasis for a long time and is similar to many metabolic related diseases. Fire needle therapy is one of the traditional Chinese specialty treatments, which has effects of warming yang to expel cold, warming and activating meridian, dispersing stasis and relieving pain. Studies have shown that fire needle therapy of plaque psoriasis in stationary phase is effective, with fewer side effects, and can reduce the recurrence rate. This multicenter, randomized, single-blind, placebo-controlled trial will objectively and standardly evaluate the clinical effectiveness, safety and control of recurrence of fire needle therapy to obtain objective evidence of international standards and form clinical norms suitable for popularization and application.
- Conditions
- Plaque Psoriasis
- Being tested
- Fire needle, Fire needle Placebo
- Keywords
- Plaque Psoriasis, Blood stasis syndrome, Randomized controlled trial, Fire Needle Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fire needleOther
- Participants wear eye masks and fully expose the lesions. After selecting the acupuncture points, the surgeon routinely disinfects the hands of the operator and the acupuncture points of the participants before the operation. After selecting an acupuncture needle with a specification of 0.4*40mm and ignites the alcohol lamp, the operator continuously moves the needle from the needle root to the needle tip to burn the red needle to disinfect the needle in the outer flame of the alcohol lamp.
- The operator ignites the alcohol lamp, and burns the needle tip and the needle body to the outer flame of the alcohol lamp until it is completely red (the length of the needle burning red is determined by the acupuncture depth), and then rapidly penetrates the skin lesion vertically, the depth of the acupuncture is based on the thickness of the skin lesion, when the operation is performed, the outer edge of the lesion is punctured to the center point, and the spacing is 0.3 to 0.5 cm.
Fire needle PlaceboOther
- Participants wear eye masks and fully expose the lesions (no lesions on the head and face, external genitalia and skin folds). After selecting the acupuncture points, the surgeon routinely disinfects the hands of the operator and the acupuncture points of the participants before the operation, then selects an acupuncture needle with a specification of 0.4*40mm to prepare for operation.
- The operator rapidly penetrates the skin lesion vertically, the depth of the acupuncture is based on the thickness of the skin lesion, when the operation is performed, the outer edge of the lesion is punctured to the center point, and the spacing is 0.3 to 0.5 cm.
| Study group | Role | What they receive |
|---|---|---|
| Fire needle group | Experimental | Participants in experimental group will receive Fire needle therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment. Receives: Other: Fire needle |
| Fire needle placebo group | Placebo comparator | Participants in experimental group will receive Fire needle placebo therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment. Receives: Other: Fire needle Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis area and severity index (PASI)
Psoriasis Area and Severity Index (PASI) involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - <10%, 2 - 10-<30%, 3 - 30-<50%, 4 - 50-<70%, 5 - 70-<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.
Measured: Up to 56 days after treatment
Secondary outcomes (6)
Body surface area (BSA)
The percentage of body surface area (BSA) involved in psoriasis is estimated by fingerprinting, where the entire palm of the patient represents approximately 1% of the total BSA. The number of handprints on psoriasis skin in a body part is used to determine the extent to which the body part is affected by psoriasis (%)
Measured: Up to 56 days after treatment
Physician Global Assessment (PGA)
Physician Global Assessment (PGA) is scored on a 5-point scale, reflecting a global consideration of the erythema (E), infiltration (I), desquamation (D) across all psoriatic lesions. It is calculated as follows: PGA score = (E + I + D) / 3, then the score needs to be rounded to the nearest whole number [PGA scale: Clear (0) - Very Severe (5)].
Measured: Up to 56 days after treatment
Dermatology Life quality index(DLQI)
The Dermatology Life Quality Index (DLQI) is a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores range from 0-30, a higher score indicating a greater impact on a participant's quality of life.
Measured: Up to 28 days after treatment
Patient-reported quality of life (PRQoL)
Patient-reported quality of life (PRQoL) is used to assess the impact of psoriasis on individual social life. Scores range from 0-25, a higher score indicating a greater impact on a participant's social life.
Measured: Up to 28 days after treatment
Visual Analogue Score (VAS)
Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 100 mm at eash visit (with 0 being no pruritis and 100 being maximum pruritis).
Measured: Up to 56 days after treatment
TCM syndrome score
The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Measured: Up to 56 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shaanxi Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Shijiazhuang Hospital of Traditional Chinese Medicine, Heilongjiang University of Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Jia Zhou, Study chair, Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953885
- Sponsor's protocol ID
- 2018YFC1705303-02
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu L, Lu Y, Yan XN, Yang SQ, Gong LP, Li LE, Zhao YD, Yin QF, Wang RP, An YP, Huang G, Zhang JF, Sun XY, Li X, Li B. Efficacy and safety of fire needle therapy for blood stasis syndrome of plaque psoriasis: protocol for a randomized, single-blind, multicenter clinical trial. Trials. 2020 Aug 25;21(1):739. doi: 10.1186/s13063-020-04691-7.
PubMed 32843084
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome: A Randomized, Single-blind, Multicentre Clinical Trial
- ClinicalTrials.gov ID
- NCT03953885
- Acronym / sponsor ID
- 2018YFC1705303-02
- Conditions
- Plaque Psoriasis
- Keywords
- Plaque Psoriasis, Blood stasis syndrome, Randomized controlled trial, Fire Needle Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Collaborators
- Shaanxi Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Shijiazhuang Hospital of Traditional Chinese Medicine, Heilongjiang University of Chinese Medicine
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 May 2019 (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 was designed as a multicenter, randomized, single blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of plaque psoriasis with blood stasis syndrome, after treated with fire needle therapy.
Detailed description
Psoriasis is a chronic inflammatory skin disease characterized by the complex interaction between the immune system, related susceptibility loci, autoantigens and various environmental factors. In China, the prevalence is about 0.47%. Current treatment strategies for psoriasis mainly focus on developing new drugs that disrupt IL-23 or IL-17 cytokine, but this targeted therapy is not effective for all patients. A growing body of evidence indicates that psoriasis-related damage is not limited to the skin, but is closely related to coronary heart disease, stroke, metabolic syndrome, and chronic kidney disease. These comorbidities have, to a certain extent, increased mortality in patients with psoriasis. Traditional Chinese medicine (TCM) has always been used to treat patients with psoriasis in China. Blood stasis syndrome is one of the basic syndromes of psoriasis. which accumulates in meridians, viscera and limbs to form a variety of syndromes with psoriasis for a long time and is similar to many metabolic related diseases. Fire needle therapy is one of the traditional Chinese specialty treatments, which has effects of warming yang to expel cold, warming and activating meridian, dispersing stasis and relieving pain. Studies have shown that fire needle therapy of plaque psoriasis in stationary phase is effective, with fewer side effects, and can reduce the recurrence rate. This multicenter, randomized, single-blind, placebo-controlled trial will objectively and standardly evaluate the clinical effectiveness, safety and control of recurrence of fire needle therapy to obtain objective evidence of international standards and form clinical norms suitable for popularization and application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fire needle group | Experimental | Other: Fire needleParticipants in experimental group will receive Fire needle therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment. |
| Fire needle placebo group | Placebo comparator | Other: Fire needle PlaceboParticipants in experimental group will receive Fire needle placebo therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Comply with the diagnostic criteria of Western medicine for plaque psoriasis and the diagnostic criteria for TCM syndromes;
- Skin lesions involve ≤10% BSA (the lesions are mainly located in the trunk and/or limbs, palm/sole, face/scalp, vulva area is not included);
- Age between 18 and 65 years old;
- Those who voluntarily participate in the study and sign informed consent.
Key exclusion criteria (12 listed)
- Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
- Other active skin diseases may affect the condition assessment;
- Received research drugs, biological agents and immunosuppressive agents within 1 month;
- 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;
- During severe, uncontrollable local or systemic acute or chronic infections;
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 |
|---|---|---|
| Fire needle1. Participants wear eye masks and fully expose the lesions. After selecting the acupuncture points, the surgeon routinely disinfects the hands of the operator and the acupuncture points of the participants before the operation. After selecting an acupuncture needle with a specification of 0.4*40mm and ignites the alcohol lamp, the operator continuously moves the needle from the needle root to the needle tip to burn the red needle to disinfect the needle in the outer flame of the alcohol lamp. 2. The operator ignites the alcohol lamp, and burns the needle tip and the needle body to the outer flame of the alcohol lamp until it is completely red (the length of the needle burning red is determined by the acupuncture depth), and then rapidly penetrates the skin lesion vertically, the depth of the acupuncture is based on the thickness of the skin lesion, when the operation is performed, the outer edge of the lesion is punctured to the center point, and the spacing is 0.3 to 0.5 cm. | Other | Fire needle group |
| Fire needle Placebo1. Participants wear eye masks and fully expose the lesions (no lesions on the head and face, external genitalia and skin folds). After selecting the acupuncture points, the surgeon routinely disinfects the hands of the operator and the acupuncture points of the participants before the operation, then selects an acupuncture needle with a specification of 0.4*40mm to prepare for operation. 2. The operator rapidly penetrates the skin lesion vertically, the depth of the acupuncture is based on the thickness of the skin lesion, when the operation is performed, the outer edge of the lesion is punctured to the center point, and the spacing is 0.3 to 0.5 cm. | Other | Fire needle placebo group |
Primary outcome
Psoriasis area and severity index (PASI)
Time frame: Up to 56 days after treatment
Psoriasis Area and Severity Index (PASI) involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - <10%, 2 - 10-<30%, 3 - 30-<50%, 4 - 50-<70%, 5 - 70-<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.
6 secondary outcomes
Body surface area (BSA)
Time frame: Up to 56 days after treatment
Physician Global Assessment (PGA)
Time frame: Up to 56 days after treatment
Dermatology Life quality index(DLQI)
Time frame: Up to 28 days after treatment
Patient-reported quality of life (PRQoL)
Time frame: Up to 28 days after treatment
Visual Analogue Score (VAS)
Time frame: Up to 56 days after treatment
TCM syndrome score
Time frame: Up to 56 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Derived from this study: PubMed 32843084Liu L, Lu Y, Yan XN, Yang SQ, Gong LP, Li LE, Zhao YD, Yin QF, Wang RP, An YP, Huang G, Zhang JF, Sun XY, Li X, Li B. Efficacy and safety of fire needle therapy for blood stasis syndrome of plaque psoriasis: protocol for a randomized, single-blind, multicenter clinical trial. Trials. 2020 Aug 25;21(1):739. doi: 10.1186/s13063-020-04691-7.
- Individual participant dataSharing planned: Undecided
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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.
Jia Zhou study chair
Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fire needle in people with Plaque Psoriasis, run by Shanghai Yueyang Integrated Medicine Hospital at 5 sites 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Li (0086-021-55981301, 18930568129@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis area and severity index (PASI) (time frame: Up to 56 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03953885, which also lists 1 linked publication.
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 17 May 2019.