Clinical trial NCT03772418: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Skin and Subcutaneous Tissue Disorders
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Measurement of ant-aging activity of Pomegranate and Ginkgo biloba
timeFrame: Three months
Secondary outcomes:
measure: Stable topical anti-aging products for long life shelf storage
timeFrame: Six months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Clinic
city: Buraidah
country: Saudi Arabia
facility: Faculty of Pharmacy
state: Qassim
city: Buraidah
country: Saudi Arabia
facility: Pharmaceutics dept., Faculty of Pharmacy, Qassim University
state: Qassim
Study officials:
affiliation: Assistant Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA
name: Ahmed Abdellatif, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.