<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03752424</url>
  </required_header>
  <id_info>
    <org_study_id>AlAzharSilver</org_study_id>
    <nct_id>NCT03752424</nct_id>
  </id_info>
  <brief_title>Topical Silver Nanoparticles for Microbial Activity</brief_title>
  <official_title>Topical Silver Nanoparticles for Microbial Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahmed A. H. Abdellatif</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Azhar University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Silver nanoparticles are one of most nanoparticles use nowadays in the research area because&#xD;
      it has specific physical and chemical properties, in medical fields silver nanoparticles can&#xD;
      involve in diagnostic and treatment processes. Silver nanoparticles have antibacterial,&#xD;
      antiviral, antifungal, antiangiogenic, antioxidant, cosmetics, antitumor, anti-inflammatory,&#xD;
      the drug carrier, imaging, water treatment, and biosensing effects. Silver nanoparticles&#xD;
      prepared with reducing agent tri-sodium citrate then incorporated in a topical cream to&#xD;
      obtain a significant inhibition of the bacterial strains, inhibition of growth of bacterial&#xD;
      strains in the face or other parts in the bodies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Preparation of vanishing cream Vanishing cream is an emulsion base which is oil in&#xD;
           water, the oil phase gives the cream shine and pearl look because of stearic acid in the&#xD;
           oil. To form an emulsion, the alkali will react with stearic acid to form stearate soap.&#xD;
           Then mix sodium hydroxide (NaOH) with potassium hydroxide (KOH) to give cream hard and&#xD;
           soft properties.&#xD;
&#xD;
        2. Preparation of cream containing silver nanoparticles Silver nanoparticles will be&#xD;
           produced by using the reduction reaction method. The reaction involves heating silver&#xD;
           nitrate at a high temperature with adding a reducing agent, the particles will produce&#xD;
           as silver nanoparticles in liquid form.&#xD;
&#xD;
        3. Characterization of the Vanishing cream containing drug:&#xD;
&#xD;
           3.1. Drug content: The amount of drug in cream will be determined by taking 100 mg of&#xD;
           the cream formulation and dissolve it in 10 mL of methanol after that it will be&#xD;
           filtrated. In addition, it will be analyzed the content of drug spectrophotometrically&#xD;
           using (UV-VIS) at specific λmax.&#xD;
&#xD;
           3.2. Irritation to skin: In this test, the cream formulation will be applied to four&#xD;
           healthy volunteers which they should not have any sensitivity to the drug. They will&#xD;
           inform about the nature of the formulation and obtain a written approval from them about&#xD;
           the irritation effect of the formulated cream.&#xD;
&#xD;
        4. Anti-microbial studies:&#xD;
&#xD;
      The antifungal action for formula will be studied using different 6 groups volunteers The&#xD;
      inhibition microbial activity for all formulae were compared with known standard&#xD;
      antimicrobial drugs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">November 13, 2019</start_date>
  <completion_date type="Anticipated">January 11, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 12, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>Six months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stable topical anti-microbial silver nanoparticles</measure>
    <time_frame>three months</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Foot Infection Fungal</condition>
  <condition>Infection, Bacterial</condition>
  <arm_group>
    <arm_group_label>Silver nanoparticles group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A group of volunteers infected with Tinea pedis, Capitis and Versicolor received Topical silver nanoparticles in different dosage forms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topical approved anti-microbial gel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo cream.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Silver nanoparticles</intervention_name>
    <description>The active group will receive silver nanoparticles in different dosage forms as an anti-microbial drug.</description>
    <arm_group_label>Silver nanoparticles group</arm_group_label>
    <other_name>Topical jel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical approved anti-microbial gel</intervention_name>
    <description>The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.</description>
    <arm_group_label>Topical approved anti-microbial gel</arm_group_label>
    <other_name>Topical anti-microbial gel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  It is important to follow up and collect data, preferably for six months for the local&#xD;
             and systemic activity of silver nanoparticles, to establish whether the infection&#xD;
             recurrent or not.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Larger numbers of participants having a different kind of skin infection are needed to&#xD;
             test efficiency drug in order to produce more reliable data.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed AH Abdellatif, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qassim University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed AH Abdellatif, Ph.D.</last_name>
    <phone>+966507726856</phone>
    <phone_ext>2014</phone_ext>
    <email>a.abdellatif@qu.edu.sa</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed AH Abdellatif, PhD</last_name>
    <phone>966507726856</phone>
    <phone_ext>14618</phone_ext>
    <email>ahmed.a.h.abdellatif@azhar.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Buraidah Clinic</name>
      <address>
        <city>Buraidah</city>
        <state>Al Qassim</state>
        <zip>51171</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed AH Abdellatif, Ph.D.</last_name>
      <phone>+966507726856</phone>
      <email>a.abdellatif@qu.edu.sa</email>
    </contact>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>24527370</PMID>
  </results_reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 10, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>October 9, 2019</last_update_submitted>
  <last_update_submitted_qc>October 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>Ahmed A. H. Abdellatif</investigator_full_name>
    <investigator_title>Assistant Professor of Pharmaceutics, Faculty of Pharmacy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Bacterial Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Infective Agents</mesh_term>
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The authors could not decide until now a plan to make individual participant data (IPD) available to other researchers.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03752424
org study id: AlAzharSilver
nct id: NCT03752424
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: 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
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.
measure: Stable topical anti-microbial silver nanoparticles
time frame: three months
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.
arm group label: Silver nanoparticles group
arm group type: Active Comparator
description: A group of volunteers infected with Tinea pedis, Capitis and Versicolor received Topical silver nanoparticles in different dosage forms.
arm group label: Topical approved anti-microbial gel
arm group type: Placebo Comparator
description: A group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo cream.
intervention type: Drug
intervention name: Silver nanoparticles
description: The active group will receive silver nanoparticles in different dosage forms as an anti-microbial drug.
arm group label: Silver nanoparticles group
other name: Topical jel
intervention type: Drug
intervention name: Topical approved anti-microbial gel
description: The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.
arm group label: Topical approved anti-microbial gel
other name: Topical anti-microbial gel
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed AH Abdellatif, PhD
role: Principal Investigator
affiliation: Qassim University
last name: Ahmed AH Abdellatif, Ph.D.
phone: +966507726856
phone ext: 2014
email: a.abdellatif@qu.edu.sa
last name: Ahmed AH Abdellatif, PhD
phone: 966507726856
phone ext: 14618
email: ahmed.a.h.abdellatif@azhar.edu.eg
facility: 
status: Recruiting
contact: 
country: Saudi Arabia
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.
PMID: 24527370
responsible party type: Sponsor-Investigator
investigator affiliation: Al-Azhar University
investigator full name: Ahmed A. H. Abdellatif
investigator title: Assistant Professor of Pharmaceutics, Faculty of Pharmacy
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Bacterial Infections
mesh term: Anti-Infective Agents
mesh term: Anti-Bacterial Agents
sharing ipd: No
ipd description: The authors could not decide until now a plan to make individual participant data (IPD) available to other researchers.