Topical Silver Nanoparticles for Microbial Activity

Sponsor
Ahmed A. H. Abdellatif (Other)
Overall Status
Unknown status
CT.gov ID
NCT03752424
Collaborator
(none)
30
1
2
14
2.1

Study Details

Study Description

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
  • 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.

  1. 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 Design

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

Arms and Interventions

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
  • Outcome Measures

    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. [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Buraidah Clinic Buraidah Al Qassim Saudi Arabia 51171

    Sponsors and Collaborators

    • Ahmed A. H. Abdellatif

    Investigators

    • Principal Investigator: Ahmed AH Abdellatif, PhD, Qassim University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed A. H. Abdellatif, Assistant Professor of Pharmaceutics, Faculty of Pharmacy, Al-Azhar University
    ClinicalTrials.gov Identifier:
    NCT03752424
    Other Study ID Numbers:
    • AlAzharSilver
    First Posted:
    Nov 26, 2018
    Last Update Posted:
    Oct 11, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 11, 2019