Evaluation of the efficacy of topical treatment with tetracycline in the prevention of cutaneous loxoscelism

Phase 3

Recruiting

• Conditions: Toxic effect of spider venom; Contact with poisonous spiders; Brown Recluse Spider; Cream for the Skin.; T63.3; B01.050.500.131.166.803.600; E02.547.800.500

• Registration Number: RBR-7jz7hm
• Lead Sponsor: Fundação de Amparo a Pesquisa do estado de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-26
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients who are victims of skin loxoscelism treated in the State of Santa Catarina will be selected and contacted by the health team and the Toxicological Assistance and Information Center (CIATox-SC) before starting any specific therapy, considering the following diagnostic criteria:
Typical cutaneous lesion, characterized by the presence of a livedoid (marmoreal) plate, surrounded by ischemic halo, accompanied or not by perilesional blisters, ecchymosis and / or endemic edema, accompanied or not by systemic manifestations;
2. Atypical cutaneous lesion with suggestive clinical history, excluding other differential diagnoses, with visceral manifestations characterized by hemolysis (to be confirmed by anemia associated with reticulocytosis, elevated bilirubin and LDH), fever, hematuria/hemoglobinuria;
3. Suggestive history, being the spider captured and the genus identified by CIATox-SC.

Sample size
Patients will be randomly divided into two groups: conventional treatment (control) and experimental treatment, in a ratio of 1: 1, for a total of 240 patients.

Inclusion criteria
Consecutive patients, of both sexes, over 18 years old, who signed a free and informed consent form with clinical diagnosis of loxoscelism treated at the health units of the municipalities of Santa Catarina, whose contact for diagnosis and therapeutic orientation be done via telephone with CIT-SC.

Exclusion Criteria

Patients who have received or applied any topical treatment for loxoscelism, those who arrive at the service with an indication of surgical procedure of the lesion (debridement of necrotic tissue), as well as the ones who refer atopy or other allergic conditions arising from the use of tetracycline. Also excluded are those who, after the introduction of therapy, have any adverse effects thereof.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Through treatment with topical tetracycline, it is expected to obtain the cure of dermonecrotic lesion, induced by the bite of the spider Loxosceles.;Through treatment with topical tetracycline, it is expected to obtain a decrease of the dermonecrotic lesion size, induced by the bite of Loxosceles spider.

Secondary Outcome Measures

Name	Time	Method
Through treatment with topical tetracycline, it is expected to obtain a decrease of in the healing time of the dermonecrotic lesion, induced by the bite of Loxosceles spider.