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

Primary Purpose

Skin and Subcutaneous Tissue Disorders

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Cream Base
Pomegrante and Ginkgo biloba group
Sponsored by
Ahmed A. H. Abdellatif
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin and Subcutaneous Tissue Disorders

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Assiut ClinicRecruiting
  • Faculty of PharmacyRecruiting
  • Pharmaceutics dept., Faculty of Pharmacy, Qassim UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Cream base

Pomegrante and Ginkgo biloba group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 15, 2018
Last Updated
December 8, 2018
Sponsor
Ahmed A. H. Abdellatif
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1. Study Identification

Unique Protocol Identification Number
NCT03772418
Brief Title
Topical Preparation of Pomegranate and Ginkgo Biloba for Anti-aging Activities
Official Title
Formulation and Evaluation of Topical Preparation Containing Pomegranate and Ginkgo Biloba for Anti-aging Activities
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 18, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
February 28, 2020 (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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin and Subcutaneous Tissue Disorders

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
Cream base
Arm Type
Placebo Comparator
Arm Description
A group of volunteers receiving placebo medications without natural extracts of ginkgo biloba and Pomegranate.
Arm Title
Pomegrante and Ginkgo biloba group
Arm Type
Active Comparator
Arm 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(s)
Cream Base
Other Intervention Name(s)
Aging group recieving placebo dosage form
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Pomegrante and Ginkgo biloba group
Other Intervention Name(s)
Aging group receive ginkgo biloba and Pomegranate
Intervention 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).
Primary Outcome Measure Information:
Title
Measurement of ant-aging activity of Pomegranate and Ginkgo biloba
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.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Stable topical anti-aging products for long life shelf storage
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.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdellatif, Ph.D.
Organizational Affiliation
Assistant Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut Clinic
City
Assiut
ZIP/Postal Code
71526
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed AH Abdellatif, PhD
Facility Name
Faculty of Pharmacy
City
Buraidah
State/Province
Qassim
ZIP/Postal Code
51452
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
Facility Name
Pharmaceutics dept., Faculty of Pharmacy, Qassim University
City
Buraidah
State/Province
Qassim
ZIP/Postal Code
51452
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
Undecided
Citations:
PubMed Identifier
15171650
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.
Results Reference
background
PubMed Identifier
28810554
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.
Results Reference
background
PubMed Identifier
22615680
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.
Results Reference
result

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

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