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

NCT04937101 | Unknown

• 1 other identifier: 2020-837
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Skin Disease

Outcome Measures

Primary Outcomes (1)

• The degree of improvement in lesion thickness

  After a treatment cycle of the lesion, the degree of improvement in the thickness of the lesion is graded according to the total score of the patient's self-evaluation and the doctor's evaluation

  1 year

Study Arms (2)

Antihistamine treatment group

EXPERIMENTAL

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

Drug: Chlorpheniramine-Codeine

Control group

NO INTERVENTION

Interventions

Chlorpheniramine-Codeine 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.

Antihistamine treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Huan Qian, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan Qian, MD

CONTACT

+8613605812646; huanqian@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 23, 2021
• Study Start: January 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-01

Locations

CN (1)