Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06396013
Other study ID # shoufa2024-2-2237
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date June 1, 2024
Est. completion date July 31, 2026

Study information

Verified date April 2024
Source Beijing Hospital of Traditional Chinese Medicine
Contact Liyun Sun
Phone +86 13521779789
Email doctorsunny@sina.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 96
Est. completion date July 31, 2026
Est. primary completion date June 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Meets the diagnostic criteria of plaque psoriasis vulgaris; 2. Meets the diagnostic criteria of plaque psoriasis with blood stasis syndrom; 3. 18 = age =65 , gender is not limited; 4. Quiescent patients; 5. Severity of the disease: mild to moderate lesions were 3=PASI=10, and 3=BSA=10; 6. Volunteers can understand the research content and sign the informed consent voluntarily. The informed consent process complies with the provisions of the GCP. Exclusion Criteria: 1. 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. 2. Received abiotic agents of systemic drug therapy within 4 weeks prior to randomization, including but not limited to systemic glucocorticoids, retinoids, methotrexate, and cyclosporine; 3. 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.); 4. Local topical psoriasis treatment, including retinoids, vitamin D3 derivatives, glucocorticoids, etc., had been received within 2 weeks before randomization; 5. Use of physical therapy within 4 weeks before randomization, including phototherapy (such as UVB, PUVA), phototherapy combined therapy, bath therapy, etc.; 6. 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; 7. 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; 8. 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; 9. Patients who have participated in clinical trials and used investigational drugs within 1 month; 10. Patients who are allergic to known components of the trial intervention; 11. 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; 12. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment
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.
placebo
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beijing Hospital of Traditional Chinese Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary tPASI targeted psoriasis area and severity index week0 2 4 6 8 10 12 16 20
Secondary PGA physician global assessment week0 2 4 6 8 10 12 16 20
Secondary target lesion area target lesion area week0 2 4 6 8 10 12 16 20
Secondary NRS numerical rating scale week0 2 4 6 8 10 12 16 20
Secondary TCM syndrome score TCM syndrome score week0 12 20
Secondary DLQI dermatology life quality index week0 12 20
Secondary SF-36 MOS 36 item short from health survey week0 12 20
Secondary the morphology and number of vascular globules under dermoscopy the morphology and number of vascular globules under dermoscopy week0 12 20
See also
  Status Clinical Trial Phase
Completed NCT01194219 - Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis Phase 3
Recruiting NCT06030076 - A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
Completed NCT04263610 - Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy Phase 4
Completed NCT02601469 - Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis Phase 2
Completed NCT05600036 - A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis Phase 2
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03614078 - A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis Phase 2
Not yet recruiting NCT05036889 - A 16-week Randomized Evaluation of the Impact of Mind.Px Application on Response to Biologic Treatment in Patients Suffering From Plaque Psoriasis Through Clinical Utility and Health Outcomes. N/A
Completed NCT04603027 - A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis Phase 2
Completed NCT03638258 - The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis Phase 2
Completed NCT02881346 - Efficacy and Tolerability of Enstilar® in Daily Practice
Recruiting NCT02611349 - Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis Phase 3
Completed NCT02251678 - Evaluate the Effect of Elimune Capsules Phase 1
Completed NCT01987843 - Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 2
Terminated NCT01708629 - Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects Phase 3
Withdrawn NCT00747032 - To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis Phase 3
Completed NCT01230138 - Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis Phase 2
Completed NCT00581100 - Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis Phase 4
Suspended NCT01228656 - Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate Phase 2
Completed NCT00540618 - A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis Phase 2