Phase I clinical study of Bacterial nanocellulose membranes modified with Poly-l-lisine-cholesterol

Phase 1

• Conditions: Wounds; Específico

• Registration Number: RBR-4g4jkrw
• Lead Sponsor: Faculdade de Enfermagem - Universidade Federal de Juiz de Fora

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-08-31
• Study Start: 2023-10-02
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

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

Inclusion Criteria

Adults aged above 18 and below 60 years; of both sexes

Exclusion Criteria

Adults without a history of infectious or parasitic diseases, infectious processes, or allergy to the components of the formulation; without the use of antimicrobials, immunosuppressants, systemic corticosteroids, and antiallergic and anti-inflammatory drugs in the last 15 days; pregnancy and breastfeeding

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmation of the safety of topical application of bacterial nanocellulose hydrogel with Poly-L-Lysine-Cholesterol (BNC-PLC)

Secondary Outcome Measures

Name	Time	Method
Optimization of the production of bacterial nanocellulose hydrogels incorporated with Poly-L-Lysine-Cholesterol for the purpose of topical application; absence of adverse effects and inflammatory signs from the topical application of BNC-PLC hydrogel on intact skin of healthy individuals through the execution of a Phase 1 clinical trial