Topical Silver Nanoparticles for Microbial Activity

Infection, Bacterial Clinical Trial

Official title:

Topical Silver Nanoparticles for Microbial Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03752424
• Other study ID #: AlAzharSilver
• Status: Recruiting
• Phase: Phase 1
• Start date: November 13, 2019
• Est. completion date: January 11, 2021

Study information

• Verified date: October 2019
• Source: Al-Azhar University
• Contact: Ahmed AH Abdellatif, Ph.D.
• Phone: +966507726856
• Email: a.abdellatif[@]qu.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 11, 2021
• Est. primary completion date: January 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Foot Infection Fungal
• Infection
• Infection, Bacterial

Intervention

Drug:
• Silver nanoparticles
The active group will receive silver nanoparticles in different dosage forms as an anti-microbial drug.
• Topical approved anti-microbial gel
The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.

Locations

Country	Name	City	State
Saudi Arabia	Buraidah Clinic	Buraidah	Al Qassim

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed A. H. Abdellatif

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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