Clinical trial NCT04937101: The Safety and Effectiveness of Local Injection of Antihistamines in Treatment of Inflammatory Skin Diseases
Official title: Human Subject Research Ethics Committee, 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Skin Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria 1. Meet the diagnostic criteria of chronic inflammatory skin disease, with limited lesions, mainly including pathological scars, isolated lesions of sarcoidosis and local hypertrophic lesions of chronic eczema; 2. Good compliance, agree not to accept the test during the test period Any local injection treatment other than treatment; 3. Voluntarily sign an informed consent form and agree to participate in all visits, inspections and treatments in accordance with the requirements of the trial protocol.

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.

Primary outcomes:
measure: The degree of improvement in lesion thickness
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Huan Qian, MD
role: PRINCIPAL_INVESTIGATOR
References: