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

Phase 1

• Conditions: Skin and Subcutaneous Tissue Disorders
• Interventions: Drug: Pomegrante and Ginkgo biloba group; Drug: Cream Base

• Registration Number: NCT03772418
• Lead Sponsor: Ahmed A. H. Abdellatif

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.

Study Timeline

• Study First Submitted: 2018-05-15
• Study Start: 2018-05-18
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-08
• Last Update Submitted: 2018-12-08
• Study First Posted: 2018-12-11
• Last Update Posted: 2018-12-11
• Primary Completion: 2020-01-01
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pomegrante and Ginkgo biloba group	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.
Cream base	Cream Base	A group of volunteers receiving placebo medications without natural extracts of ginkgo biloba and Pomegranate.

Primary Outcome Measures

Name	Time	Method
Measurement of ant-aging activity of Pomegranate and Ginkgo biloba	Three months	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

Name	Time	Method
Stable topical anti-aging products for long life shelf storage	Six months	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.

Trial Locations

Locations (3)

Assiut Clinic; 🇪🇬 Assiut, Egypt

Faculty of Pharmacy; 🇸🇦 Buraidah, Qassim, Saudi Arabia

Pharmaceutics dept., Faculty of Pharmacy, Qassim University; 🇸🇦 Buraidah, Qassim, Saudi Arabia