Topical Silver Nanoparticles for Microbial Activity

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.

Study Overview

• Status: Unknown
• Conditions: Infection, Bacterial; Foot Infection Fungal
• Intervention / Treatment: Drug: Silver nanoparticles; Drug: Topical approved anti-microbial gel

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ahmed AH Abdellatif, Ph.D.; Phone Number: 2014 +966507726856; Email: a.abdellatif@qu.edu.sa
• Study Contact Backup: Name: Ahmed AH Abdellatif, PhD; Phone Number: 14618 966507726856; Email: ahmed.a.h.abdellatif@azhar.edu.eg

Study Locations

• Saudi Arabia
  • Al Qassim
    • Buraidah, Al Qassim, Saudi Arabia, 51171
      • Recruiting
      • Buraidah Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Silver nanoparticles group; A group of volunteers infected with Tinea pedis, Capitis and Versicolor received Topical silver nanoparticles in different dosage forms.	Drug: Silver nanoparticles; The active group will receive silver nanoparticles in different dosage forms as an anti-microbial drug.; Other Names: Topical jel
Placebo Comparator: Topical approved anti-microbial gel; A group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo cream.	Drug: Topical approved anti-microbial gel; The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.; Other Names: Topical anti-microbial gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stable topical anti-microbial silver nanoparticles	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.	three months

Collaborators and Investigators

• Sponsor: Ahmed A. H. Abdellatif

Publications and helpful links

General Publications

• Gunasekaran T, Nigusse T, Dhanaraju MD. Silver nanoparticles as real topical bullets for wound healing. J Am Coll Clin Wound Spec. 2012 Jun 4;3(4):82-96. doi: 10.1016/j.jcws.2012.05.001. eCollection 2011 Dec.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 13, 2019
• Primary Completion (Anticipated): January 12, 2020
• Study Completion (Anticipated): January 11, 2021

Study Registration Dates

• First Submitted: November 10, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: AlAzharSilver

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The authors could not decide until now a plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No