Topical Silver Nanoparticles for Microbial Activity

NCT03752424 | Unknown Phase 1 DMC

• 1 other identifier: AlAzharSilver
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Infection Fungal; Infection, Bacterial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Stable topical anti-microbial silver nanoparticles

  three months

Study Arms (2)

Silver nanoparticles group

ACTIVE COMPARATOR

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

Drug: Silver nanoparticles

Topical approved anti-microbial gel

PLACEBO COMPARATOR

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

Drug: Topical approved anti-microbial gel

Interventions

Silver nanoparticles DRUG

The active group will receive silver nanoparticles in different dosage forms as an anti-microbial drug.

Also known as: Topical jel

Silver nanoparticles group

Topical approved anti-microbial gel DRUG

The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.

Also known as: Topical anti-microbial gel

Topical approved anti-microbial gel

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ahmed A. H. Abdellatif: lead

Study Sites (1)

Buraidah Clinic

Buraidah, Al Qassim, 51171, Saudi Arabia

RECRUITING

Related 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.

  PMID: 24527370 RESULT

MeSH Terms

Conditions

Bacterial Infections

Interventions

colloidal silver

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Ahmed AH Abdellatif, PhD

  Qassim University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed AH Abdellatif, Ph.D.

CONTACT

+966507726856; a.abdellatif@qu.edu.sa

Ahmed AH Abdellatif, PhD

CONTACT

966507726856; ahmed.a.h.abdellatif@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pharmaceutics, Faculty of Pharmacy

Study Record Dates

• First Submitted: November 10, 2018
• First Posted: November 26, 2018
• Study Start: November 13, 2019
• Primary Completion: January 12, 2020
• Study Completion: January 11, 2021
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)