Effects of topical application of Silver-Nimesulide Complex in the Treatment of Patients with Squamous Cell Carcinoma of the Skin

Effects of topical application of Silver-Nimesulide Complex in the Treatment of Patients with Skin Squamous Cell Carcinoma: Phase I/II Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-3csjgb8

Enrollment

Registered

2026-02-09

Start date

2026-03-12

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Squamous Cell

Interventions

The study will evaluate the medicinal intervention through the topical application of a biocurative containing the silver–nimesulide complex (CB-Ag-NMS). This is an open-label, non-randomized, single-

Eligibility

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Men and women aged 18 years or older and under 90 years; confirmed diagnosis of cutaneous squamous cell carcinoma. Tumors with a minimum diameter of 1cm and superficially located in the skin. Surgical tumor resection previously scheduled; ensuring a minimum interval of 42 days between the initiation of treatment with the silver–nimesulide biocurative (CB-Ag-NMS) and the surgical procedure. Signed or recorded Informed Consent Form (ICF)

Exclusion criteria

Exclusion criteria: Participants with lesions located on the face. Lesions near superficial blood vessels. Ulcerated tumor. Dermatological comorbidities that may interfere with clinical evaluation. Known hypersensitivity to silver; nimesulide or adhesive materials. Pregnant or breastfeeding women. Immunosuppressed individuals. Participants who do not have a previously scheduled tumor resection surgery at the Institution

Design outcomes

Primary

Measure	Time frame
To evaluate the cutaneous and systemic safety of silver–nimesulide biocurative CB-Ag-NMS based on the absence of clinical signs of local or systemic toxicity;To evaluate the local efficacy of the treatment through the total or partial reduction of tumor volume at the end of the intervention period;To evaluate the cutaneous pharmacokinetic profile of silver–nimesulide (Ag-NMS) by determining its penetration and concentration within the skin layers	—

Measure

Time frame

To evaluate the cutaneous and systemic safety of silver–nimesulide biocurative CB-Ag-NMS based on the absence of clinical signs of local or systemic toxicity;To evaluate the local efficacy of the treatment through the total or partial reduction of tumor volume at the end of the intervention period;To evaluate the cutaneous pharmacokinetic profile of silver–nimesulide (Ag-NMS) by determining its penetration and concentration within the skin layers

—

Secondary

Measure	Time frame
To assess and characterize the mechanism of action of the silver–nimesulide biocurative (CB-Ag-NMS)	—

Countries

Brazil

Contacts

Public ContactGisele da Silva

Universidade Estadual de Campinas

giselegs@unicamp.br+55(19)35218936

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026