NCT03772418

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2018

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

May 18, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

1.6 years

First QC Date

May 15, 2018

Last Update Submit

December 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Stable topical anti-aging products for long life shelf storage

    Six months

Study Arms (2)

Cream base

PLACEBO COMPARATOR

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

Drug: Cream Base

Pomegrante and Ginkgo biloba group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Aging group recieving placebo dosage form
Cream base

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).

Also known as: Aging group receive ginkgo biloba and Pomegranate
Pomegrante and Ginkgo biloba group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Insulin-dependent diabetes
  • Hypertension disease
  • Skin wound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Assiut Clinic

Asyut, 71526, Egypt

RECRUITING

Faculty of Pharmacy

Buraidah, Al-Qassim Region, 51452, Saudi Arabia

RECRUITING

Pharmaceutics dept., Faculty of Pharmacy, Qassim University

Buraidah, Al-Qassim Region, 51452, Saudi Arabia

RECRUITING

Related Publications (3)

  • 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: 15171650BACKGROUND
  • 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: 28810554BACKGROUND
  • 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.

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • Ahmed Abdellatif, Ph.D.

    Assistant Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed AH Abdellatif, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA

Study Record Dates

First Submitted

May 15, 2018

First Posted

December 11, 2018

Study Start

May 18, 2018

Primary Completion

January 1, 2020

Study Completion

February 28, 2020

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations