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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03772418
Other study ID # AlAzharPGB
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 18, 2018
Est. completion date February 28, 2020

Study information

Verified date December 2018
Source Al-Azhar University
Contact Ahmed AH Abdellatif, Ph.D.
Phone +966507726856
Email a.abdellatif@qu.edu.sa
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date February 28, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Skin and Subcutaneous Tissue Disorders

Intervention

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.
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).

Locations

Country Name City State
Egypt Assiut Clinic Assiut
Saudi Arabia Faculty of Pharmacy Buraidah Qassim
Saudi Arabia Pharmaceutics dept., Faculty of Pharmacy, Qassim University Buraidah Qassim

Sponsors (1)

Lead Sponsor Collaborator
Ahmed A. H. Abdellatif

Countries where clinical trial is conducted

Egypt,  Saudi Arabia, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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