Topical Silver Nanoparticles for Microbial Activity
Primary Purpose
Foot Infection Fungal, Infection, Bacterial
Status
Unknown status
Phase
Phase 1
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Silver nanoparticles
Topical approved anti-microbial gel
Sponsored by
About this trial
This is an interventional treatment trial for Foot Infection Fungal
Eligibility 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.
Sites / Locations
- Buraidah ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Silver nanoparticles group
Topical approved anti-microbial gel
Arm Description
A group of volunteers infected with Tinea pedis, Capitis and Versicolor received Topical silver nanoparticles in different dosage forms.
A group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo cream.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03752424
First Posted
November 10, 2018
Last Updated
October 9, 2019
Sponsor
Ahmed A. H. Abdellatif
1. Study Identification
Unique Protocol Identification Number
NCT03752424
Brief Title
Topical Silver Nanoparticles for Microbial Activity
Official Title
Topical Silver Nanoparticles for Microbial Activity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 13, 2019 (Anticipated)
Primary Completion Date
January 12, 2020 (Anticipated)
Study Completion Date
January 11, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed A. H. Abdellatif
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
Detailed Description
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.
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Infection Fungal, Infection, Bacterial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Silver nanoparticles group
Arm Type
Active Comparator
Arm Description
A group of volunteers infected with Tinea pedis, Capitis and Versicolor received Topical silver nanoparticles in different dosage forms.
Arm Title
Topical approved anti-microbial gel
Arm Type
Placebo Comparator
Arm Description
A group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo cream.
Intervention Type
Drug
Intervention Name(s)
Silver nanoparticles
Other Intervention Name(s)
Topical jel
Intervention Description
The active group will receive silver nanoparticles in different dosage forms as an anti-microbial drug.
Intervention Type
Drug
Intervention Name(s)
Topical approved anti-microbial gel
Other Intervention Name(s)
Topical anti-microbial gel
Intervention Description
The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Stable topical anti-microbial silver nanoparticles
Description
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.
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed AH Abdellatif, Ph.D.
Phone
+966507726856
Ext
2014
Email
a.abdellatif@qu.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed AH Abdellatif, PhD
Phone
966507726856
Ext
14618
Email
ahmed.a.h.abdellatif@azhar.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed AH Abdellatif, PhD
Organizational Affiliation
Qassim University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buraidah Clinic
City
Buraidah
State/Province
Al Qassim
ZIP/Postal Code
51171
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed AH Abdellatif, Ph.D.
Phone
+966507726856
Email
a.abdellatif@qu.edu.sa
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The authors could not decide until now a plan to make individual participant data (IPD) available to other researchers.
Citations:
PubMed Identifier
24527370
Citation
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.
Results Reference
result
Learn more about this trial
Topical Silver Nanoparticles for Microbial Activity
We'll reach out to this number within 24 hrs