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

Primary Purpose

Inflammatory Skin Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Chlorpheniramine-Codeine

About this trial

This is an interventional treatment trial for Inflammatory Skin Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Antihistamine treatment group

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04937101

First Posted

June 16, 2021

Last Updated

June 16, 2021

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04937101

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

December 30, 2021 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Skin Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Antihistamine treatment group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Chlorpheniramine-Codeine

Intervention Description

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.

Primary Outcome Measure Information:

Title

The degree of improvement in lesion thickness

Description

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huan Qian, MD

Phone

+8613605812646

huanqian@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huan Qian, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Human Subject Research Ethics Committee Human Subject Research Ethics Committee

Phone

+86 0571 87783759

keyanlunli_zheer@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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