The Safety and Effectiveness of Local Injection of Antihistamines in Treatment of Inflammatory Skin Diseases

NCT ID: NCT04937101

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-12-30

Brief Summary

The treatment of chronic inflammatory skin diseases is a difficult point in clinical diseases, which mainly include patients with pathological scars, sarcoidosis and chronic eczema. Chronic nodular lesions and long-term itching symptoms bring great physical and mental pain to patients.

Long-term repeated treatments are required. At present, the most commonly used treatment is intralesional injection of glucocorticoids. Long-term glucocorticoid injections have some side effects, including pain, hypopigmentation, skin atrophy, pigmentation, telangiectasia and menstrual disorders in women. There are a large number of clinical patients who still lack safe and effective drugs, including children, pregnant women, patients with weakened or defective immunity, and even patients with mild inflammatory skin diseases with mainly itching symptoms.

The systemic and topical application of antihistamine drugs provides new ideas for the treatment of inflammatory skin. As the most commonly used clinical antihistamine, chlorpheniramine has a long history in the treatment of allergic diseases and can improve the body's inflammatory state. At the same time, the drug has high safety and is suitable for children and pregnant women, or patients with underlying diseases such as hypertension, diabetes, and immunodeficiency diseases.

Detailed Description

At present, there are more and more reports about the application of antihistamines to the treatment of pathological scars. Exposing fibroblasts from normal skin and keloids to the antihistamine diphenhydramine can inhibit the growth of keloid fibroblasts . Based on the existing research foundation in the field and the results of our previous laboratory experiments, we hypothesize that intralesional injection of chlorpheniramine can improve the pruritus symptoms and the severity of skin lesions in inflammatory skin diseases, and can be used as a new application of traditional medicine.

Conditions

Inflammatory Skin Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antihistamine treatment group

Chlorpheniramine, the concentration is 10mg/ml per unit point, the highest dose is 1ml

Group Type: EXPERIMENTAL

Chlorpheniramine-Codeine

Intervention Type: DRUG

When the filter tester is sensitive, he opened the random letter group envelope to the notification letter manager and jointly confirmed the classification of the message group. The test group used the chlorpheniramine beacon, the physiological surface was used, and the local lesions of fine particles were used in the focus. Injection therapy. No form of anesthesia is used during injection. A total of injection treatment, at intervals, each treatment and the last treatment, treatment and safety after 1 month.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Chlorpheniramine-Codeine

When the filter tester is sensitive, he opened the random letter group envelope to the notification letter manager and jointly confirmed the classification of the message group. The test group used the chlorpheniramine beacon, the physiological surface was used, and the local lesions of fine particles were used in the focus. Injection therapy. No form of anesthesia is used during injection. A total of injection treatment, at intervals, each treatment and the last treatment, treatment and safety after 1 month.

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

1. Those who have received triamcinolone acetonide injection treatment in the lesion area within the past year; 2. Those who have precancerous skin lesions or have a tendency to become cancerous, or those who have received local radiation therapy on their skin; 3. There are skin infections, inflammations, herpes, and silver Those with active skin diseases such as scaly; 4. Those who have autoimmune diseases or are receiving immunotherapy; 5. Those who have coagulation dysfunction or are using anticoagulant/antiplatelet drugs; 6. Those who have other serious diseases, such as liver and kidney Insufficiency, diabetes, high blood pressure, etc.; 7. Women who are planning to become pregnant, pregnant or breastfeeding; 8. People who suffer from mental illness, or are currently taking antipsychotic drugs; 9. Other conditions that the investigator considers inappropriate to participate in this trial , Such as high expectations, poor compliance.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huan Qian, MD

Role: PRINCIPAL_INVESTIGATOR

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huan Qian, MD

Role: CONTACT

huanqian@zju.edu.cn

+8613605812646

Facility Contacts

Human Subject Research Ethics Committee Human Subject Research Ethics Committee

Role: primary

keyanlunli_zheer@163.com

+86 0571 87783759

Other Identifiers

2020-837

Identifier Type: -

Identifier Source: org_study_id