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

Human Subject Research Ethics Committee, 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Skin Disease
• Intervention / Treatment: Drug: Chlorpheniramine-Codeine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Human Subject Research Ethics Committee Human Subject Research Ethics Committee; Phone Number: +86 0571 87783759; Email: keyanlunli_zheer@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Antihistamine treatment group; Chlorpheniramine, the concentration is 10mg/ml per unit point, the highest dose is 1ml	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Huan Qian, MD, 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dermatitis; Skin Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Dermatologic Agents; Analgesics, Opioid; Narcotics; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Antitussive Agents; Codeine; Chlorpheniramine
• Other Study ID Numbers: 2020-837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No