Efficacy and safety of fuzhiqing ointment in the treatment of perianal chronic eczema: a prospective, randomized, double-blind, controlled multicenter study

Phase 4

• Conditions: perianal chronic eczema; EA87.2

• Registration Number: ITMCTR2000004179
• Lead Sponsor: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) The age ranged from 18 to 65 years old;
(2) It was in accordance with the diagnostic criteria of perianal chronic eczema;
(3) The subjects voluntarily signed a written informed consent form.

Exclusion Criteria

(1) Eczema is found in the area outside the perianal skin;
(2) Other active skin diseases (such as psoriasis, acne, syphilis, skin tuberculosis, lupus erythematosus, perioral dermatitis and acne vulgaris) that may affect the evaluation of the results.
(3) There are serious diseases of heart, lung, liver, kidney, nerve, endocrine and other systems.
(4) The laboratory examined the ALT >=60u/l, and the serum creatinine (CR) was more than 106 umol/l or bun was more than 7.14mmol/l;
(5) The infection of bacteria, fungi or virus in the local or drug-use areas of skin lesions needs anti infection treatment;
(6) The patients who had been treated with antihistamines within 2 weeks, who had received ultraviolet light therapy within 4 weeks, who had systemic application of aspirin, glucocorticoids or immunosuppressants within 4 weeks; those who used topical drugs in local skin lesions within 1 week, including skin moisturizers;
(7) The drug with similar composition and chemical structure is known to have allergy history; the drug has a history of hypersensitivity to food and drug;
(8) Participated in other clinical researchers of experimental drugs within 1 month;
(9) Alcohol, drug abuse, known drug dependence;
(10) Pregnant, prospective or lactating women and staff directly involved in the study;
(11) Mental illness patients;
(12) The researchers judged that it was not suitable for other cases to participate in clinical research.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DLQI;EASI;SF-36;Pruritus score;

Secondary Outcome Measures

Name	Time	Method
Recurrence rate;Skindex16;Patients' self rating eczema severity score;POEM;Effective time;SCORAD index;WHOQOL-BREF;EQ-5D;Insomnia score;