Clinical trial

Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal

Name
MR-37-23-008382
Description
Each year, millions of burn, trauma, or surgical patients worldwide suffer from scarring that severely affects their quality of life and social functioning. In order to prevent and treat diseases related to abnormal scar hyperplasia, clinicians and researchers have adopted various methods, such as scar grinding, surgical resection, drug injection in scar tissue, cryotherapy, laser and so on. However, these methods can not effectively inhibit the abnormal proliferation of scars and improve the adverse effects of existing scars on patients. To date, there is no accepted gold standard for the effective treatment and improvement of abnormal scar tissue.
Trial arms
Trial start
2023-03-23
Estimated PCD
2023-10-10
Trial end
2024-03-31
Status
Completed
Phase
Early phase I
Treatment
Botulinum toxin type A
Eligible patients were randomly assigned to the experimental group and the control group. Patients in the experimental group will be randomized to receive injections of 1 U,2.5 U, and 5 U botulinum toxin type A,Patients in the control group received an injection of 0.9% Nacl
Arms:
Injection 0.9%Nacl, Injection 1 U / 0.1ml BTXA, Injection 2.5U / 0.1ml BTXA, Injection 5U / 0.1ml BTXA
Other names:
0.9%Nacl
Size
50
Primary endpoint
The modified Stony Brook Scar Evaluation Scale
Postoperative 7 days, 15 days, 1 month, 3 months, 6 months
Eligibility criteria
Inclusion Criteria: Patients with emergency trauma and skin swellings, with clear consciousness, no mental retardation or cognitive difficulties, agree to participate in this study, 12≤ age ≤ 65 years old Exclusion Criteria: Allergic to botulinum toxin type A;Pregnant, lactating women, patients who plan to get pregnant in the near future;Patients taking retinoic acid, synthetic steroids, amino glycosides antibiotics, calcium channel blockers, cyclosporine and cholinesterase inhibitors; 4 Neuromuscular diseases: such as myasthenia gravis, Lambert-Eaton syndrome, multiple sclerosis;5. Patients with cardiovascular diseases, kidney diseases, liver and other basic diseases; 6 Patients with infection at the injection site; 7 Expect unrealistic patients.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2024-05-31

1 organization

1 product

1 indication

Organization
Dezhou Hospital
Indication
Scar