Topical Silver Nanoparticles for Microbial Activity

Ahmed A. H. Abdellatif

Status and phase: Unknown; Phase 1

Conditions: Foot Infection Fungal; Infection, Bacterial

Treatments: Drug: Topical approved anti-microbial gel; Drug: Silver nanoparticles

Study type: Interventional

Funder types: Other

Identifiers

NCT03752424

AlAzharSilver

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Silver nanoparticles group

Active Comparator group

Description:

A group of volunteers infected with Tinea pedis, Capitis and Versicolor received Topical silver nanoparticles in different dosage forms.

Treatment:

Drug: Silver nanoparticles

Topical approved anti-microbial gel

Placebo Comparator group

Description:

A group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo cream.

Treatment:

Drug: Topical approved anti-microbial gel