Topical Silver Nanoparticles for Microbial Activity

Phase 1

• Conditions: Foot Infection Fungal; Infection, Bacterial
• Interventions: Drug: Silver nanoparticles; Drug: Topical approved anti-microbial gel

• Registration Number: NCT03752424
• Lead Sponsor: Ahmed A. H. Abdellatif

Brief Summary

Silver nanoparticles are one of most nanoparticles use nowadays in the research area because it has specific physical and chemical properties, in medical fields silver nanoparticles can involve in diagnostic and treatment processes. Silver nanoparticles have antibacterial, antiviral, antifungal, antiangiogenic, antioxidant, cosmetics, antitumor, anti-inflammatory, the drug carrier, imaging, water treatment, and biosensing effects. Silver nanoparticles prepared with reducing agent tri-sodium citrate then incorporated in a topical cream to obtain a significant inhibition of the bacterial strains, inhibition of growth of bacterial strains in the face or other parts in the bodies.

Detailed Description

1. Preparation of vanishing cream Vanishing cream is an emulsion base which is oil in water, the oil phase gives the cream shine and pearl look because of stearic acid in the oil. To form an emulsion, the alkali will react with stearic acid to form stearate soap. Then mix sodium hydroxide (NaOH) with potassium hydroxide (KOH) to give cream hard and soft properties.

2. Preparation of cream containing silver nanoparticles Silver nanoparticles will be produced by using the reduction reaction method. The reaction involves heating silver nitrate at a high temperature with adding a reducing agent, the particles will produce as silver nanoparticles in liquid form.

3. Characterization of the Vanishing cream containing drug:

3.1. Drug content: The amount of drug in cream will be determined by taking 100 mg of the cream formulation and dissolve it in 10 mL of methanol after that it will be filtrated. In addition, it will be analyzed the content of drug spectrophotometrically using (UV-VIS) at specific λmax.

3.2. Irritation to skin: In this test, the cream formulation will be applied to four healthy volunteers which they should not have any sensitivity to the drug. They will inform about the nature of the formulation and obtain a written approval from them about the irritation effect of the formulated cream.

4. Anti-microbial studies:

The antifungal action for formula will be studied using different 6 groups volunteers The inhibition microbial activity for all formulae were compared with known standard antimicrobial drugs.

Study Timeline

• Study First Submitted: 2018-11-10
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-26
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-09
• Last Update Posted: 2019-10-11
• Study Start: 2019-11-13
• Primary Completion: 2020-01-12
• Study Completion: 2021-01-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• It is important to follow up and collect data, preferably for six months for the local and systemic activity of silver nanoparticles, to establish whether the infection recurrent or not.

Exclusion Criteria

• Larger numbers of participants having a different kind of skin infection are needed to test efficiency drug in order to produce more reliable data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver nanoparticles group	Silver nanoparticles	A group of volunteers infected with Tinea pedis, Capitis and Versicolor received Topical silver nanoparticles in different dosage forms.
Topical approved anti-microbial gel	Topical approved anti-microbial gel	A group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo cream.

Primary Outcome Measures

Name	Time	Method
The antimicrobial activity of silver nanoparticles in the two groups of control and an infected patient will be determined. Each group will be of 6 volunteers, each one will be controlled for the CTCAE.	Six months	The formulated silver nanoparticles are expected to be with anti-microbial after applying activity with infected patients even systemically or topically. The nanoparticles will be examined on two groups of patients (control group, and patient with fungal or microbial infections). Moreover, the obtained silver nanoparticles are expected to highly internalized and disease targeted. The results will be compared with control groups to prove the anti-microbial Activity. The progress of treating the patient will be noticed by completely disappear of fungal infection.

Secondary Outcome Measures

Name	Time	Method
Stable topical anti-microbial silver nanoparticles	three months	Stability test will be studied for dosage forms. The test will carried out by standing the products on shelf life for three months. The stability test will be recorded using high performance liquid chromatography each thee days.

Trial Locations

Locations (1)

Buraidah Clinic; 🇸🇦 Buraidah, Al Qassim, Saudi Arabia