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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000004179
Enrollment
Unknown
Registered
2020-09-30
Start date
2020-10-15
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

perianal chronic eczema

Interventions

control group:triamcinolone acetonide and econazole cream
Observation group:External use of fuzhiqing ointment

Sponsors

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
DLQI;EASI;SF-36;Pruritus score;

Secondary

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

Countries

China

Contacts

Public ContactSUN SONGPENG

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

sspbeijing@126.com+86 13911511971

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026