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

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

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.

Study Overview

• Status: Unknown
• Conditions: Skin and Subcutaneous Tissue Disorders
• Intervention / Treatment: Drug: Cream Base; Drug: Pomegrante and Ginkgo biloba group

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71526
    • Recruiting
    • Assiut Clinic
    • Contact: Ahmed AH Abdellatif, PhD
• Saudi Arabia
  • Qassim
    • Buraidah, Qassim, Saudi Arabia, 51452
      • Recruiting
      • Faculty of Pharmacy
    • Buraidah, Qassim, Saudi Arabia, 51452
      • Recruiting
      • Pharmaceutics dept., Faculty of Pharmacy, Qassim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of ant-aging activity of Pomegranate and Ginkgo biloba	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.	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stable topical anti-aging products for long life shelf storage	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.	Six months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): February 28, 2020

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: December 8, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 8, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: AlAzharPGB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No