<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/NCT03772418</url>
  </required_header>
  <id_info>
    <org_study_id>AlAzharPGB</org_study_id>
    <nct_id>NCT03772418</nct_id>
  </id_info>
  <brief_title>Topical Preparation of Pomegranate and Ginkgo Biloba for Anti-aging Activities</brief_title>
  <official_title>Formulation and Evaluation of Topical Preparation Containing Pomegranate and Ginkgo Biloba for Anti-aging Activities</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>
      As the quality of life improves, people are seeking to look as young as they feel. Ginkgo&#xD;
      biloba (GB) and Pomegranate (PG) extract can be used to create efficacious topical anti-aging&#xD;
      products. GB &amp; PG are now widely used in research and clinical trials on age-associated&#xD;
      diseases, for example, skin aging, brain dysfunction, cardiovascular system diseases,&#xD;
      carcinogen metabolism. The investigator's aim is to formulate a topical cream in the form&#xD;
      (O/W or W/O emulsion) formulation, containing GB as an anti-aging formulation for the public.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, a vanishing cream will be prepared by reaction of a stearic acid with alkali&#xD;
      (NaOH) to form stearate soap. Then the GB extract will be added to the final form. The&#xD;
      formulated cream will be characterized for identifying the type of emulsion, calibration&#xD;
      curve for GB, drug content, irritation to skin, homogeneity test, pH, FT-IR test, ex vivo&#xD;
      studies, physical stability, and human application. Finally, a 9-questions questionnaire was&#xD;
      published using Google forms for the human volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 18, 2018</start_date>
  <completion_date type="Anticipated">February 28, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 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>Measurement of ant-aging activity of Pomegranate and Ginkgo biloba</measure>
    <time_frame>Three months</time_frame>
    <description>The crow's feet wrinkle of 17 volunteers will be measured compared to the control group. The significant results will measure the decrease in the depths of deep furrows for groups treated with Pomegranate and Ginkgo biloba over a three months period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stable topical anti-aging products for long life shelf storage</measure>
    <time_frame>Six months</time_frame>
    <description>Stability test will be studied for dosage forms. The test will be carried out by standing the products on shelf life for six 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>Skin and Subcutaneous Tissue Disorders</condition>
  <arm_group>
    <arm_group_label>Cream base</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A group of volunteers receiving placebo medications without natural extracts of ginkgo biloba and Pomegranate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pomegrante and Ginkgo biloba group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A group of volunteers with the aging state receiving natural extracts of ginkgo biloba and Pomegranate in different topical dosage forms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cream Base</intervention_name>
    <description>The formulated dosage form without ginkgo biloba or pomegranate will be applied to the 30 aging people who are suffering from wrinkles in the skin male and female. Typically, will be applied on two groups, one man (Group 0a) and one woman were (Group 0b) which they will be used plain cream.</description>
    <arm_group_label>Cream base</arm_group_label>
    <other_name>Aging group recieving placebo dosage form</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pomegrante and Ginkgo biloba group</intervention_name>
    <description>The extracts of ginkgo biloba and Pomegranate as formulated in topical dosage form will be applied to the 30 aging people who are suffering from wrinkles in the skin male and female. Formulated cream will be applied on two groups, one man (Group Ia)and one woman (Group Ib).</description>
    <arm_group_label>Pomegrante and Ginkgo biloba group</arm_group_label>
    <other_name>Aging group receive ginkgo biloba and Pomegranate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of aging shape&#xD;
&#xD;
          -  Follow up and collect data for a local and systemic activity of Ginkgo Biloba and&#xD;
             Pomegranate&#xD;
&#xD;
          -  The skin should be not injured as the cream can be easily applied&#xD;
&#xD;
          -  Systemic oral capsule Ginkgo Biloba and Pomegranate can be also given to enhance the&#xD;
             activity as anti-aging activity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insulin-dependent diabetes&#xD;
&#xD;
          -  Hypertension disease&#xD;
&#xD;
          -  Skin wound&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Abdellatif, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA</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>
  <location>
    <facility>
      <name>Assiut Clinic</name>
      <address>
        <city>Assiut</city>
        <zip>71526</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed AH Abdellatif, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Faculty of Pharmacy</name>
      <address>
        <city>Buraidah</city>
        <state>Qassim</state>
        <zip>51452</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>
    <facility>
      <name>Pharmaceutics dept., Faculty of Pharmacy, Qassim University</name>
      <address>
        <city>Buraidah</city>
        <state>Qassim</state>
        <zip>51452</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>Egypt</country>
    <country>Saudi Arabia</country>
  </location_countries>
  <reference>
    <citation>Dong LY, Fan L, Li GF, Guo Y, Pan J, Chen ZW. [Anti-aging action of the total lactones of ginkgo on aging mice]. Yao Xue Xue Bao. 2004 Mar;39(3):176-9. Chinese.</citation>
    <PMID>15171650</PMID>
  </reference>
  <reference>
    <citation>Kang SJ, Choi BR, Kim SH, Yi HY, Park HR, Song CH, Ku SK, Lee YJ. Beneficial effects of dried pomegranate juice concentrated powder on ultraviolet B-induced skin photoaging in hairless mice. Exp Ther Med. 2017 Aug;14(2):1023-1036. doi: 10.3892/etm.2017.4626. Epub 2017 Jun 16.</citation>
    <PMID>28810554</PMID>
  </reference>
  <results_reference>
    <citation>Rasul A, Akhtar N. Formulation and in vivo evaluation for anti-aging effects of an emulsion containing basil extract using non- invasive biophysical techniques. Daru. 2011;19(5):344-50.</citation>
    <PMID>22615680</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>May 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 8, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 8, 2018</last_update_submitted>
  <last_update_submitted_qc>December 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</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 Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03772418
org study id: AlAzharPGB
nct id: NCT03772418
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
As the quality of life improves, people are seeking to look as young as they feel. Ginkgo
      biloba (GB) and Pomegranate (PG) extract can be used to create efficacious topical anti-aging
      products. GB & PG are now widely used in research and clinical trials on age-associated
      diseases, for example, skin aging, brain dysfunction, cardiovascular system diseases,
      carcinogen metabolism. The investigator's aim is to formulate a topical cream in the form
      (O/W or W/O emulsion) formulation, containing GB as an anti-aging formulation for the public.
In this study, a vanishing cream will be prepared by reaction of a stearic acid with alkali
      (NaOH) to form stearate soap. Then the GB extract will be added to the final form. The
      formulated cream will be characterized for identifying the type of emulsion, calibration
      curve for GB, drug content, irritation to skin, homogeneity test, pH, FT-IR test, ex vivo
      studies, physical stability, and human application. Finally, a 9-questions questionnaire was
      published using Google forms for the human volunteers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Measurement of ant-aging activity of Pomegranate and Ginkgo biloba
time frame: Three months
description: The crow's feet wrinkle of 17 volunteers will be measured compared to the control group. The significant results will measure the decrease in the depths of deep furrows for groups treated with Pomegranate and Ginkgo biloba over a three months period.
measure: Stable topical anti-aging products for long life shelf storage
time frame: Six months
description: Stability test will be studied for dosage forms. The test will be carried out by standing the products on shelf life for six months. The stability test will be recorded using high-performance liquid chromatography each thee days.
arm group label: Cream base
arm group type: Placebo Comparator
description: A group of volunteers receiving placebo medications without natural extracts of ginkgo biloba and Pomegranate.
arm group label: Pomegrante and Ginkgo biloba group
arm group type: Active Comparator
description: A group of volunteers with the aging state receiving natural extracts of ginkgo biloba and Pomegranate in different topical dosage forms.
intervention type: Drug
intervention name: Cream Base
description: The formulated dosage form without ginkgo biloba or pomegranate will be applied to the 30 aging people who are suffering from wrinkles in the skin male and female. Typically, will be applied on two groups, one man (Group 0a) and one woman were (Group 0b) which they will be used plain cream.
arm group label: Cream base
other name: Aging group recieving placebo dosage form
intervention type: Drug
intervention name: Pomegrante and Ginkgo biloba group
description: The extracts of ginkgo biloba and Pomegranate as formulated in topical dosage form will be applied to the 30 aging people who are suffering from wrinkles in the skin male and female. Formulated cream will be applied on two groups, one man (Group Ia)and one woman (Group Ib).
arm group label: Pomegrante and Ginkgo biloba group
other name: Aging group receive ginkgo biloba and Pomegranate
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed Abdellatif, Ph.D.
role: Principal Investigator
affiliation: Assistant Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA
last name: Ahmed AH Abdellatif, Ph.D.
phone: +966507726856
phone ext: 2014
email: a.abdellatif@qu.edu.sa
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Egypt
country: Saudi Arabia
citation: Dong LY, Fan L, Li GF, Guo Y, Pan J, Chen ZW. [Anti-aging action of the total lactones of ginkgo on aging mice]. Yao Xue Xue Bao. 2004 Mar;39(3):176-9. Chinese.
PMID: 15171650
citation: Kang SJ, Choi BR, Kim SH, Yi HY, Park HR, Song CH, Ku SK, Lee YJ. Beneficial effects of dried pomegranate juice concentrated powder on ultraviolet B-induced skin photoaging in hairless mice. Exp Ther Med. 2017 Aug;14(2):1023-1036. doi: 10.3892/etm.2017.4626. Epub 2017 Jun 16.
PMID: 28810554
citation: Rasul A, Akhtar N. Formulation and in vivo evaluation for anti-aging effects of an emulsion containing basil extract using non- invasive biophysical techniques. Daru. 2011;19(5):344-50.
PMID: 22615680
responsible party type: Sponsor-Investigator
investigator affiliation: Al-Azhar University
investigator full name: Ahmed A. H. Abdellatif
investigator title: Assistant Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA
mesh term: Skin Diseases
sharing ipd: Undecided