Scalp PsoriasisNCT04801433
Evaluate the Efficacy and Safety of Boroda Supramolecular Active Zinc in the Treatment of Scalp Psoriasis
A study testing Boleda Supramolecular Active Zinc Conditioner, Capotetriol scalp solution and Supramolecular Hydrogel in people with Scalp Psoriasis, run by Xijing Hospital at 1 site in China.
Trial summary
A multicenter, randomized, single-blind, parallel-controlled clinical study to evaluate the efficacy and safety of boroda supramolecular active zinc in the treatment of scalp psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- Boleda Supramolecular Active Zinc Conditioner, Capotetriol scalp solution and Supramolecular Hydrogel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2018to 25 Nov 2019
- 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
- Age between 18-65，regardless of gender；
- Clinically diagnosed as scalp psoriasis and severity of the disease：
- According to the researchers evaluation of clinical signs, each of the three clinical signs of scalp psoriasis, erythema, infiltration and scales, needs to be < 3 points, and at least one sign score is ≥ 1.
- <25% of the total scalp area (the fully expanded flat palm (including the surface of five fingers) is equivalent to approximately 25% of the scalp area).
- The judgment of mild to moderate outcome need to be in accordance with the overall evaluation criteria;
- At the time of admission, the skin lesions of the body and limbs of the subjects need to have clinical signs of psoriasis vulgaris (the maximum surface of the affected area is ≤10%) or had been diagnosed as psoriasis vulgaris on the body and limbs at the early stage.
- Subjects must sign a informed consent of notification in prior to the study;
Who cannot join
- Subjects are diagnosed with active guttate psoriasis, pustular psoriasis, arthropathy psoriasis and erythroderma psoriasis at present.
- The subjects scalp associated with other diseases that may affect the judgment of curative effect: such as, viral infection, fungal infection, bacterial infection, parasitic infection, skin manifestations associated with syphilis or tuberculosis, rosacea, acne, post-acne inflammation, skin atrophy, atrophic stria, increased skin venous vulnerability, ichthyosis, ulcer or wound that skin manifestations related to injury;
- Any infectious skin disease that confuses the evaluation of the efficacy of scalp psoriasis
- The subjects that had received systemic biotherapy (listed or not listed) in the past three months of randomized enrollment that may have potential effects on scalp psoriasis, such as alefaxer, legalizumab, etanercept, infliximab, etc.
- The subjects who had received non-biological systemic therapies that may have an impact on scalp psoriasis, such as corticosteroids, vitamin D-type drugs, Tretinoin, immunosuppressive agents, etc. in 4 weeks before the 2nd screening visit or during the study period.
- Randomly enrolled (1st visit) subjects who have received PUVA treatment 4 weeks before or during the study period;
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- Randomly enrolled (1st visit) subjects that had received ultraviolet therapy 2 weeks before or during the study period;
- The subjects that had received the following treatments 2 weeks before the 2nd screening or during the study period:
- Strong or extremely effective steroid hormone external preparations for psoriasis on the body and limbs (WHO Class III-IV);
- External immunomodulators (such as tacrolimus ointment, etc.)
- External use of vitamin D analogues (e.g. captopril preparation, tacalcitol and calcitriol);
- External treatment of various types of scalp psoriasis (except for shampoos or softeners that are not steroid drugs);
- Other treatments for psoriasis: such as traditional Chinese medicine or Chinese patent medicine, hot springs, etc.
- During the study period, it is planned to start or change the use of concomitant drugs that may affect scalp psoriasis, such as beta-blockers, antimalarials, lithium preparations, etc.
- Subjects who are known or suspected to be allergic to the drug components in the study;
- Pregnant or fertile female intend to be pregnant or lactating during the study period;
- In the 2nd screening visit, the serum or urine pregnancy test of fertile women is positive.
- The subjects who participated in other clinical trials within 4 weeks of randomization;
- The subjects with known or suspected poor compliance who could not complete the tests, such as alcoholism, drug dependence or mental illness, or the subjects who are not suitable to participate in this clinical research that determined by the researchers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Study to Evaluate the Efficacy and Safety of Boroda Supramolecular Active Zinc in the Treatment of Scalp Psoriasis
A multicenter, randomized, single-blind, parallel-controlled clinical study to evaluate the efficacy and safety of boroda supramolecular active zinc in the treatment of scalp psoriasis.
Main objective:：Compare the efficacy of boroda supramolecular active zinc and capotetriol liniment in the treatment of scalp psoriasis Secondary objective: To observe the safety of boroda supramolecular active zinc in the treatment of subjects with scalp psoriasis
- Conditions
- Scalp Psoriasis
- Being tested
- Boleda Supramolecular Active Zinc Conditioner, Capotetriol scalp solution, Supramolecular Hydrogel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boleda Supramolecular Active Zinc ConditionerOther
Boleda Supramolecular Active Zinc Conditioner (Shanghai Ruizhi Pharmaceutical Technology Co., Ltd.): 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water.
Capotetriol scalp solutionDrug
Capotetriol scalp solution: 30ml/bottle. Two times a day for 4 weeks, topically applied to scalp psoriasis.
Supramolecular HydrogelOther
Supramolecular Hydrogel (Shanghai Ruizhi Pharmaceutical Technology Co., Ltd.): 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water.
| Study group | Role | What they receive |
|---|---|---|
| Boleda Supramolecular Active Zinc | Experimental | Boleda Supramolecular Active Zinc (Shanghai Ruizhi Pharmaceutical Technology Co., Ltd.): 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water. Receives: Other: Boleda Supramolecular Active Zinc Conditioner |
| Capotetriol scalp solution | Active comparator | 30ml/bottle. Two times a day for 4 weeks, topically applied to scalp psoriasis. Receives: Drug: Capotetriol scalp solution |
| Supramolecular Hydrogel | Placebo comparator | 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water. Receives: Other: Supramolecular Hydrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate at the end of treatment (4th week) in each group (percentage of patients with overall score of < 1)
The overall criteria for assessing the severity of disease for researchers are a static skin scoring system consisting of six levels (score of 0-5) of change from "disappearance" to "very serious" diseases.
The main endpoint of the overall assessment criteria for disease severity according to the researchers will be "disease control", defined as "disappearance (score of 0) " or "extreme mild (score of 1) " disease grade at the end of treatment.
At the end of treatment, the proportion of the subjects who are evaluated as disease under control (signs disappeared and extremely mild) by "the overall assessment of the severity of disease by researchers" base on observation. Comparing the disease control rates among the groups can reflect the differentiation treatment efficacy.
Measured: Change of success rate from baseline at 4 weeks
The clinical signs of psoriasis (erythema, infiltration, and scaly) (The Total sign score (TSS))
Scoring each symptom once on the basis of the five-point system given below can assess the average severity of all scalp lesions.
0 = no sign
- = Mild
- = Medium
- = Severity
- = Extremely severe
At the end of treatment, researchers need to evaluate scalp psoriasis in all subjects from three aspects: erythema, infiltration and scales. The percentage of remission per clinical sign (erythema, infiltration, scales) in each group (percentage of patients with clinical score = 0).
Measured: Change of sclinical signs of psoriasis from baseline at 4 weeks
Secondary outcomes (1)
Evaluation criteria of pruritus symptoms in the subjects
At the end of treatment, the subject are assessed for the severity of the disease according to the four-level system presented below. Researchers should explain the grading criteria to patients, and the subjects should judge the grading and tick it.
- Asymptomatic: no itching;
- Mild: mild itching, no irritation;
- Moderate: markedly itchy, somewhat irritable, but no insomnia;
- Severe: Strong itching causes significant irritability, affects sleep, and scratches are visible.
Measured: Change of spruritus symptoms from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start30 Nov 2018
- Primary completion4 Jul 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp PsoriasisStudies of the same condition, open and under way.
- More trials run by Xijing 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Wang, MD, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801433
- Sponsor's protocol ID
- XijingH-PF-Pso-2018/2019
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Study to Evaluate the Efficacy and Safety of Boroda Supramolecular Active Zinc in the Treatment of Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT04801433
- Acronym / sponsor ID
- XijingH-PF-Pso-2018/2019
- Conditions
- Scalp Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 17 Mar 2021 (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.
A multicenter, randomized, single-blind, parallel-controlled clinical study to evaluate the efficacy and safety of boroda supramolecular active zinc in the treatment of scalp psoriasis.
Main objective:：Compare the efficacy of boroda supramolecular active zinc and capotetriol liniment in the treatment of scalp psoriasis Secondary objective: To observe the safety of boroda supramolecular active zinc in the treatment of subjects with scalp psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Boleda Supramolecular Active Zinc | Experimental | Other: Boleda Supramolecular Active Zinc ConditionerBoleda Supramolecular Active Zinc (Shanghai Ruizhi Pharmaceutical Technology Co., Ltd.): 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water. |
| Capotetriol scalp solution | Active comparator | Drug: Capotetriol scalp solution30ml/bottle. Two times a day for 4 weeks, topically applied to scalp psoriasis. |
| Supramolecular Hydrogel | Placebo comparator | Other: Supramolecular Hydrogel30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18-65，regardless of gender；
- Clinically diagnosed as scalp psoriasis and severity of the disease：
- At the time of admission, the skin lesions of the body and limbs of the subjects need to have clinical signs of psoriasis vulgaris (the maximum surface of the affected area is ≤10%) or had been diagnosed as psoriasis vulgaris on the body and limbs at the early stage.
- Subjects must sign a informed consent of notification in prior to the study;
Key exclusion criteria (19 listed)
- Subjects are diagnosed with active guttate psoriasis, pustular psoriasis, arthropathy psoriasis and erythroderma psoriasis at present.
- The subjects scalp associated with other diseases that may affect the judgment of curative effect: such as, viral infection, fungal infection, bacterial infection, parasitic infection, skin manifestations associated with syphilis or tuberculosis, rosacea, acne, post-acne inflammation, skin atrophy, atrophic stria, increased skin venous vulnerability, ichthyosis, ulcer or wound that skin manifestations related to injury;
- Any infectious skin disease that confuses the evaluation of the efficacy of scalp psoriasis
- The subjects that had received systemic biotherapy (listed or not listed) in the past three months of randomized enrollment that may have potential effects on scalp psoriasis, such as alefaxer, legalizumab, etanercept, infliximab, etc.
- The subjects who had received non-biological systemic therapies that may have an impact on scalp psoriasis, such as corticosteroids, vitamin D-type drugs, Tretinoin, immunosuppressive agents, etc. in 4 weeks before the 2nd screening visit or during the study period.
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 |
|---|---|---|
| Boleda Supramolecular Active Zinc ConditionerBoleda Supramolecular Active Zinc Conditioner (Shanghai Ruizhi Pharmaceutical Technology Co., Ltd.): 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water. | Other | Boleda Supramolecular Active Zinc |
| Capotetriol scalp solutionCapotetriol scalp solution: 30ml/bottle. Two times a day for 4 weeks, topically applied to scalp psoriasis. | Drug | Capotetriol scalp solution |
| Supramolecular HydrogelSupramolecular Hydrogel (Shanghai Ruizhi Pharmaceutical Technology Co., Ltd.): 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water. | Other | Supramolecular Hydrogel |
Primary outcome
Success rate at the end of treatment (4th week) in each group (percentage of patients with overall score of < 1)
Time frame: Change of success rate from baseline at 4 weeks
The overall criteria for assessing the severity of disease for researchers are a static skin scoring system consisting of six levels (score of 0-5) of change from "disappearance" to "very serious" diseases. The main endpoint of the overall assessment criteria for disease severity according to the researchers will be "disease control", defined as "disappearance (score of 0) " or "extreme mild (score of 1) " disease grade at the end of treatment. At the end of treatment, the proportion of the subjects who are evaluated as disease under control (signs disappeared and extremely mild) by "the overall assessment of the severity of disease by researchers" base on observation. Comparing the disease control rates among the groups can reflect the differentiation treatment efficacy.
The clinical signs of psoriasis (erythema, infiltration, and scaly) (The Total sign score (TSS))
Time frame: Change of sclinical signs of psoriasis from baseline at 4 weeks
Scoring each symptom once on the basis of the five-point system given below can assess the average severity of all scalp lesions. 0 = no sign 1. = Mild 2. = Medium 3. = Severity 4. = Extremely severe At the end of treatment, researchers need to evaluate scalp psoriasis in all subjects from three aspects: erythema, infiltration and scales. The percentage of remission per clinical sign (erythema, infiltration, scales) in each group (percentage of patients with clinical score = 0).
1 secondary outcome
Evaluation criteria of pruritus symptoms in the subjects
Time frame: Change of spruritus symptoms from baseline at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boleda Supramolecular Active Zinc Conditioner, Capotetriol scalp solution and Supramolecular Hydrogel in people with Scalp Psoriasis, run by Xijing Hospital 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 7 inclusion and 19 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 17 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Success rate at the end of treatment (4th week) in each group (percentage of patients with overall score of < 1) (time frame: Change of success rate from baseline at 4 weeks). The study lists 2 primary outcomes in all. 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 17 Mar 2021.