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Topical Preparation of Pomegranate and Ginkgo Biloba for Anti-aging Activities

Sponsor
Ahmed A. H. Abdellatif (Other)
Overall Status
Unknown status
CT.gov ID
NCT03772418
Collaborator
(none)
30
Enrollment
3
Locations
2
Arms
21.4
Anticipated Duration (Months)
10
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cream Base
  • Drug: Pomegrante and Ginkgo biloba group
 Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Formulation and Evaluation of Topical Preparation Containing Pomegranate and Ginkgo Biloba for Anti-aging Activities
Actual Study Start Date :
May 18, 2018
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Feb 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Cream base

A group of volunteers receiving placebo medications without natural extracts of ginkgo biloba and Pomegranate.

Drug: Cream Base
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.
Other Names:
  • Aging group recieving placebo dosage form

    		•
    Active Comparator: Pomegrante and Ginkgo biloba group

    A group of volunteers with the aging state receiving natural extracts of ginkgo biloba and Pomegranate in different topical dosage forms.

    Drug: Pomegrante and Ginkgo biloba group
    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).
    Other Names:
  • Aging group receive ginkgo biloba and Pomegranate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measurement of ant-aging activity of Pomegranate and Ginkgo biloba [Three months]

      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.

    Secondary Outcome Measures

    1. Stable topical anti-aging products for long life shelf storage [Six months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Clinical diagnosis of aging shape

    • Follow up and collect data for a local and systemic activity of Ginkgo Biloba and Pomegranate

    • The skin should be not injured as the cream can be easily applied

    • Systemic oral capsule Ginkgo Biloba and Pomegranate can be also given to enhance the activity as anti-aging activity

    Exclusion Criteria:

    • Insulin-dependent diabetes

    • Hypertension disease

    • Skin wound

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut Clinic Assiut Egypt 71526
    2 Faculty of Pharmacy Buraidah Qassim Saudi Arabia 51452
    3 Pharmaceutics dept., Faculty of Pharmacy, Qassim University Buraidah Qassim Saudi Arabia 51452

    Sponsors and Collaborators

    • Ahmed A. H. Abdellatif

    Investigators

    • Principal Investigator: Ahmed Abdellatif, Ph.D., Assistant Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ahmed A. H. Abdellatif, Assistant Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA, Al-Azhar University
    ClinicalTrials.gov Identifier:
    NCT03772418
    Other Study ID Numbers:
    • AlAzharPGB
    First Posted:
    Dec 11, 2018
    Last Update Posted:
    Dec 11, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Skin Diseases

    Study Results

    No Results Posted as of Dec 11, 2018