Plaque PsoriasisPhase 1NCT06396013
A Multicentre Randomized Controlled Clinical Study on the Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment Therapy for Psoriasis With Blood Stasis Syndrome.
A Phase 1 study testing Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment in people with Plaque Psoriasis, run by Beijing Hospital of Traditional Chinese Medicine.
Trial summary
Background: Psoriasis is one of the hot spots in the field of skin disease prevention and treatment, and TCM topical preparations have unique advantages in the treatment of psoriasis. 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?
- Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 31 Jul 2026
- Phase
- Phase 1
- 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
- Meets the diagnostic criteria of plaque psoriasis vulgaris;
- Meets the diagnostic criteria of plaque psoriasis with blood stasis syndrom;
- 18 ≤ age ≤65 , gender is not limited;
- Quiescent patients;
- Severity of the disease: mild to moderate lesions were 3≤PASI≤10, and 3≤BSA≤10;
- Volunteers can understand the research content and sign the informed consent voluntarily. The informed consent process complies with the provisions of the GCP.
Who cannot join
- psoriasis induced by drug factors; Combined with non-plaque psoriasis (i.e. guttate, joint, pustule, erythroderma, or other types of psoriasis); Skin lesions were found only in special parts of the face, scalp, nails, creases, glans, mucous membranes, palms and plantar.
- Received abiotic agents of systemic drug therapy within 4 weeks prior to randomization, including but not limited to systemic glucocorticoids, retinoids, methotrexate, and cyclosporine;
- Received biologics within 12 weeks or 5 half-lives prior to randomization (whatever is longer), including but not limited to interleukin antibodies (e.g. Usinumab, secuchiumab, etc.) and tumor necrosis factor a antagonists (e.g. Etanercepp, infliximab, adalimumab, etc.);
- Local topical psoriasis treatment, including retinoids, vitamin D3 derivatives, glucocorticoids, etc., had been received within 2 weeks before randomization;
- Use of physical therapy within 4 weeks before randomization, including phototherapy (such as UVB, PUVA), phototherapy combined therapy, bath therapy, etc.;
- systemic anti-infection therapy within 4 weeks prior to randomization; A recurrent, chronic, or active infection at baseline that the investigator determined would increase the subject's risk;
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- with a serious, progressive, or uncontrolled disease, including but not limited to past or current autoimmune disease (such as: Rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc.) or diseases of the endocrine system, blood system, urinary system, hepatobiliary system, respiratory system, nervous system, mental system, cardiovascular system, gastrointestinal system or infectious diseases, malignant tumors; A history of drug abuse, alcohol/drug abuse;
- Patients with serum creatinine higher than the upper limit of normal, glutamic pyruvic transaminase or glutamic oxalacetic transaminase level ≥1.5 times the upper limit of normal;
- Patients who have participated in clinical trials and used investigational drugs within 1 month;
- Patients who are allergic to known components of the trial intervention;
- The patient (including the partner) has a pregnancy plan from 2 weeks before the first dose to 1 month after the last dose or is unwilling to take effective contraceptive measures during pregnancy or lactation;
- There are circumstances that other investigators consider unsuitable for study participation, such as subjects with other skin problems that hinder the evaluation of psoriasis, potential compliance problems, inability to complete all examinations and evaluations as required by the protocol, and uncontrollable risks to study participation.
Trial locations and contacts
No sites are listed yet.
About this study
Background: Psoriasis is one of the hot spots in the field of skin disease prevention and treatment, and TCM topical preparations have unique advantages in the treatment of psoriasis. The Qinteng Huoxue prescription series of TCM topical preparations created by Professor Sun Liyun have been observed to be effective in clinical practice in the treatment of psoriasis, but there is no multi-center clinical trial for blood stasis syndrome. In addition, the TCM topical preparations has the disadvantages of large particle diameter and unfavorable penetration of skin barrier.
Objective: In this study, chitosan nanocrystalline drug delivery system was used to prepare Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment, and the efficacy and safety of Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment in the intervention of psoriasis with blood stasis syndrome was investigated through multi-center, randomized, double-blind, self-controlled bilateral skin lesions and placebo-controlled clinical trials.
Read more
Methods: A total of 96 patients with plaque psoriasis with blood stasis syndrome of were enrolled in 4 research centers, and bilateral symmetrical rashes on limbs or trunk were selected, and randomly divided into experimental group and control group. The experimental group received topical Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment, twice a day for 12 weeks, and the control group received topical placebo twice a day for 12 weeks, and two follow-up visits were performed at the 16th and 20th week.
Results Indicators: The main efficacy indicators were targeted psoriasis area and severity index (tPASI), and the secondary efficacy indicators included: Psoriasis physician global assessment (PGA), target lesion area, numerical rating scale (NRS), TCM syndrome score, dermatology life quality index (DLQI), MOS 36 item short from health survey (SF-36)), and the morphology and number of vascular globules under dermoscopy. tPASI, PGA, target lesion area, NRS were assessed at baseline, at 2, 4, 6, 8, 10, 12 weeks of treatment, and at 16 and 20 weeks of follow-up. TCM syndrome score, DLQI, SF-36, and dermoscopy were assessed at baseline, 12 and 20 weeks. Safety assessment includes vital signs monitoring, blood routine, urine routine, liver and kidney function tests, and adverse events and adverse reactions. SPSS 20.0 was used for data analysis.
- Conditions
- Plaque Psoriasis
- Being tested
- Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment, placebo
- Keywords
- Plaque psoriasis, blood stasis syndrome, Qinteng Huoxue Runji Ointment, chitosan, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chitosan Nanocrystalline Qinteng Huoxue Runji OintmentDrug
Also called TCM decoction Huoxue Sanyu Decoction, Loratadine
Basic treatment: According to the recommendations of the Guidelines, all participant took the traditional Chinese medicine decoction Huoxue Sanyu Decoction orally. 2 times/day for 12 weeks.
Acute administration: When the participant has unbearable itching, the doctor can give loratadine tablet 10mg orally once a night, and record the dosage and frequency of use.
placeboDrug
Also called Loratadine
Basic treatment: According to the recommendations of the Guidelines, all participant took the traditional Chinese medicine decoction Huoxue Sanyu Decoction orally. 2 times/day for 12 weeks.
Acute administration: When the participant has unbearable itching, the doctor can give loratadine tablet 10mg orally once a night, and record the dosage and frequency of use.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The experimental group received topical Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment, twice a day for 12 weeks Receives: Drug: Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment |
| control group | Placebo comparator | The control group received topical placebo twice a day for 12 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
tPASI
targeted psoriasis area and severity index
Measured: week0 2 4 6 8 10 12 16 20
Secondary outcomes (7)
PGA
physician global assessment
Measured: week0 2 4 6 8 10 12 16 20
target lesion area
target lesion area
Measured: week0 2 4 6 8 10 12 16 20
NRS
numerical rating scale
Measured: week0 2 4 6 8 10 12 16 20
TCM syndrome score
TCM syndrome score
Measured: week0 12 20
DLQI
dermatology life quality index
Measured: week0 12 20
SF-36
MOS 36 item short from health survey
Measured: week0 12 20
the morphology and number of vascular globules under dermoscopy
the morphology and number of vascular globules under dermoscopy
Measured: week0 12 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liyun Sun, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396013
- Sponsor's protocol ID
- shoufa2024-2-2237
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomized Controlled Clinical Study on the Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment Therapy for Psoriasis With Blood Stasis Syndrome.
- ClinicalTrials.gov ID
- NCT06396013
- Acronym / sponsor ID
- shoufa2024-2-2237
- Conditions
- Plaque Psoriasis
- Keywords
- Plaque psoriasis, blood stasis syndrome, Qinteng Huoxue Runji Ointment, chitosan, randomized controlled trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 2 May 2024 (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.
Background: Psoriasis is one of the hot spots in the field of skin disease prevention and treatment, and TCM topical preparations have unique advantages in the treatment of psoriasis. The Qinteng Huoxue prescription series of TCM topical preparations created by Professor Sun Liyun have been observed to be effective in clinical practice in the treatment of psoriasis, but there is no multi-center clinical trial for blood stasis syndrome. In addition, the TCM topical preparations has the disadvantages of large particle diameter and unfavorable penetration of skin barrier.
Objective: In this study, chitosan nanocrystalline drug delivery system was used to prepare Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment, and the efficacy and safety of Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment in the intervention of psoriasis with blood stasis syndrome was investigated through multi-center, randomized, double-blind, self-controlled bilateral skin lesions and placebo-controlled clinical trials.
Methods: A total of 96 patients with plaque psoriasis with blood stasis syndrome of were enrolled in 4 research centers, and bilateral symmetrical rashes on limbs or trunk were selected, and randomly divided into experimental group and control group. The experimental group received topical Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment, twice a day for 12 weeks, and the control group received topical placebo twice a day for 12 weeks, and two follow-up visits were performed at the 16th and 20th week.
Results Indicators: The main efficacy indicators were targeted psoriasis area and severity index (tPASI), and the secondary efficacy indicators included: Psoriasis physician global assessment (PGA), target lesion area, numerical rating scale (NRS), TCM syndrome score, dermatology life quality index (DLQI), MOS 36 item short from health survey (SF-36)), and the morphology and number of vascular globules under dermoscopy. tPASI, PGA, target lesion area, NRS were assessed at baseline, at 2, 4, 6, 8, 10, 12 weeks of treatment, and at 16 and 20 weeks of follow-up. TCM syndrome score, DLQI, SF-36, and dermoscopy were assessed at baseline, 12 and 20 weeks. Safety assessment includes vital signs monitoring, blood routine, urine routine, liver and kidney function tests, and adverse events and adverse reactions. SPSS 20.0 was used for data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Chitosan Nanocrystalline Qinteng Huoxue Runji OintmentThe experimental group received topical Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment, twice a day for 12 weeks |
| control group | Placebo comparator | Drug: placeboThe control group received topical placebo twice a day for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meets the diagnostic criteria of plaque psoriasis vulgaris;
- Meets the diagnostic criteria of plaque psoriasis with blood stasis syndrom;
- 18 ≤ age ≤65 , gender is not limited;
- Quiescent patients;
- Severity of the disease: mild to moderate lesions were 3≤PASI≤10, and 3≤BSA≤10;
Key exclusion criteria (12 listed)
- psoriasis induced by drug factors; Combined with non-plaque psoriasis (i.e. guttate, joint, pustule, erythroderma, or other types of psoriasis); Skin lesions were found only in special parts of the face, scalp, nails, creases, glans, mucous membranes, palms and plantar.
- Received abiotic agents of systemic drug therapy within 4 weeks prior to randomization, including but not limited to systemic glucocorticoids, retinoids, methotrexate, and cyclosporine;
- Received biologics within 12 weeks or 5 half-lives prior to randomization (whatever is longer), including but not limited to interleukin antibodies (e.g. Usinumab, secuchiumab, etc.) and tumor necrosis factor a antagonists (e.g. Etanercepp, infliximab, adalimumab, etc.);
- Local topical psoriasis treatment, including retinoids, vitamin D3 derivatives, glucocorticoids, etc., had been received within 2 weeks before randomization;
- Use of physical therapy within 4 weeks before randomization, including phototherapy (such as UVB, PUVA), phototherapy combined therapy, bath therapy, etc.;
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 |
|---|---|---|
| Chitosan Nanocrystalline Qinteng Huoxue Runji OintmentAlso: TCM decoction Huoxue Sanyu Decoction, LoratadineBasic treatment: According to the recommendations of the Guidelines, all participant took the traditional Chinese medicine decoction Huoxue Sanyu Decoction orally. 2 times/day for 12 weeks. Acute administration: When the participant has unbearable itching, the doctor can give loratadine tablet 10mg orally once a night, and record the dosage and frequency of use. | Drug | experimental group |
| placeboAlso: LoratadineBasic treatment: According to the recommendations of the Guidelines, all participant took the traditional Chinese medicine decoction Huoxue Sanyu Decoction orally. 2 times/day for 12 weeks. Acute administration: When the participant has unbearable itching, the doctor can give loratadine tablet 10mg orally once a night, and record the dosage and frequency of use. | Drug | control group |
Primary outcome
tPASI
Time frame: week0 2 4 6 8 10 12 16 20
targeted psoriasis area and severity index
7 secondary outcomes
PGA
Time frame: week0 2 4 6 8 10 12 16 20
target lesion area
Time frame: week0 2 4 6 8 10 12 16 20
NRS
Time frame: week0 2 4 6 8 10 12 16 20
TCM syndrome score
Time frame: week0 12 20
DLQI
Time frame: week0 12 20
SF-36
Time frame: week0 12 20
the morphology and number of vascular globules under dermoscopy
Time frame: week0 12 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment in people with Plaque Psoriasis, run by Beijing Hospital of Traditional Chinese Medicine.
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 6 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 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Liyun Sun (+86 13521779789, doctorsunny@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tPASI (time frame: week0 2 4 6 8 10 12 16 20). 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 2 May 2024.