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Topical Silver Nanoparticles for Microbial Activity

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ClinicalTrials.gov Identifier: NCT03752424
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed A. H. Abdellatif, Al-Azhar University

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.

Condition or disease Intervention/treatment Phase
Foot Infection Fungal Infection, Bacterial Drug: Silver nanoparticles Drug: Topical approved anti-microbial gel Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Topical Silver Nanoparticles for Microbial Activity
Estimated Study Start Date : January 13, 2019
Estimated Primary Completion Date : January 12, 2020
Estimated Study Completion Date : January 11, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 Name: 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 Name: Topical anti-microbial gel




Primary Outcome Measures :
  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. [ Time Frame: 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 :
  1. Stable topical anti-microbial silver nanoparticles [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752424


Contacts
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Contact: Ahmed AH Abdellatif, Ph.D. +966507726856 ext 2014 a.abdellatif@qu.edu.sa
Contact: Ahmed AH Abdellatif

Locations
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Saudi Arabia
Buraidah Clinic Recruiting
Buraidah, Al Qassim, Saudi Arabia, 51171
Contact: Ahmed AH Abdellatif, Ph.D.    +966507726856    a.abdellatif@qu.edu.sa   
Sponsors and Collaborators
Ahmed A. H. Abdellatif

Publications of Results:
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Responsible Party: Ahmed A. H. Abdellatif, Assistant Professor of Pharmaceutics, Faculty of Pharmacy, Al-Azhar University
ClinicalTrials.gov Identifier: NCT03752424     History of Changes
Other Study ID Numbers: AlAzharSilver
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Mycoses
Anti-Bacterial Agents
Anti-Infective Agents