Evaluate the Efficacy and Safety of Boroda Supramolecular Active Zinc in the Treatment of Scalp Psoriasis

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Scalp Psoriasis

Treatments: Other: Supramolecular Hydrogel; Other: Boleda Supramolecular Active Zinc Conditioner; Drug: Capotetriol scalp solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04801433

XijingH-PF-Pso-2018/2019

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18-65，regardless of gender；

2. 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;

3. 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.

4. Subjects must sign a informed consent of notification in prior to the study;

Exclusion criteria

1. Subjects are diagnosed with active guttate psoriasis, pustular psoriasis, arthropathy psoriasis and erythroderma psoriasis at present.

2. 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;

3. Any infectious skin disease that confuses the evaluation of the efficacy of scalp psoriasis

4. 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.

5. 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.

6. Randomly enrolled (1st visit) subjects who have received PUVA treatment 4 weeks before or during the study period;

7. Randomly enrolled (1st visit) subjects that had received ultraviolet therapy 2 weeks before or during the study period;

8. The subjects that had received the following treatments 2 weeks before the 2nd screening or during the study period:

   1. Strong or extremely effective steroid hormone external preparations for psoriasis on the body and limbs (WHO Class III-IV);
   2. External immunomodulators (such as tacrolimus ointment, etc.)
   3. External use of vitamin D analogues (e.g. captopril preparation, tacalcitol and calcitriol);
   4. External treatment of various types of scalp psoriasis (except for shampoos or softeners that are not steroid drugs);
   5. Other treatments for psoriasis: such as traditional Chinese medicine or Chinese patent medicine, hot springs, etc.

9. 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.

10. Subjects who are known or suspected to be allergic to the drug components in the study;

11. Pregnant or fertile female intend to be pregnant or lactating during the study period;

12. In the 2nd screening visit, the serum or urine pregnancy test of fertile women is positive.

13. The subjects who participated in other clinical trials within 4 weeks of randomization;

14. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 3 patient groups, including a placebo group

Boleda Supramolecular Active Zinc

Experimental group

Description:

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.

Treatment:

Other: Boleda Supramolecular Active Zinc Conditioner

Capotetriol scalp solution

Active Comparator group

Description:

30ml/bottle. Two times a day for 4 weeks, topically applied to scalp psoriasis.

Treatment:

Drug: Capotetriol scalp solution

Supramolecular Hydrogel

Placebo Comparator group

Description:

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.

Treatment:

Other: Supramolecular Hydrogel