Dermatology Derpartment of Xijing Hospital
Xi'an, Shaanxi, 710032, China
NCT Number: NCT04801433
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
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Xi'an, Shaanxi, 710032, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 solution: 30ml/bottle. Two times a day for 4 weeks, topically applied to scalp psoriasis.
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.
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.
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
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).
Time frame: Change of spruritus symptoms from baseline at 4 weeks
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.
Xijing Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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