Skin and Subcutaneous Tissue DisordersPhase 1NCT03772418
Topical Preparation of Pomegranate and Ginkgo Biloba for Anti-aging Activities
A Phase 1 study testing Cream Base and Pomegrante and Ginkgo biloba group in people with Skin and Subcutaneous Tissue Disorders, run by Ahmed A. H. Abdellatif at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin and Subcutaneous Tissue Disorders
- What is being tested?
- Cream Base and Pomegrante and Ginkgo biloba group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 May 2018to 28 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Insulin-dependent diabetes
- Hypertension disease
- Skin wound
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Saudi Arabia2 sites, 2 recruiting
- Recruiting
Faculty of Pharmacy
Buraidah, Al-Qassim Region, 51452
Ahmed AH Abdellatif, Ph.D., +966507726856, a.abdellatif@qu.edu.sa
- Recruiting
Pharmaceutics dept., Faculty of Pharmacy, Qassim University
Buraidah, Al-Qassim Region, 51452
Ahmed AH Abdellatif, Ph.D., +966507726856, a.abdellatif@qu.edu.sa
Egypt1 site, 1 recruiting
- Recruiting
Assiut Clinic
Asyut, 71526
Ahmed AH Abdellatif, PhD
About this study
Official title: Formulation and Evaluation of Topical Preparation Containing Pomegranate and Ginkgo Biloba for Anti-aging Activities
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.
Read the 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.
- Conditions
- Skin and Subcutaneous Tissue Disorders
- Being tested
- Cream Base, Pomegrante and Ginkgo biloba group
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cream BaseDrug
Also called Aging group recieving placebo dosage form
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 groupDrug
Also called Aging group receive ginkgo biloba and Pomegranate
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).
| Study group | Role | What they receive |
|---|---|---|
| Cream base | Placebo comparator | A group of volunteers receiving placebo medications without natural extracts of ginkgo biloba and Pomegranate. Receives: 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. Receives: Drug: Pomegrante and Ginkgo biloba group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months
Secondary outcomes (1)
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start18 May 2018
- Primary completion1 Jan 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Skin and Subcutaneous Tissue DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed A. H. Abdellatif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed A. H. Abdellatif, Al-Azhar University
- Investigators
- Ahmed Abdellatif, Ph.D., Principal investigator, Assistant Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772418
- Sponsor's protocol ID
- AlAzharPGB
- Status last verified
- Dec 2018
- First submitted
- 15 May 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15171650Kang 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.
PubMed 28810554Rasul 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.
PubMed 22615680
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formulation and Evaluation of Topical Preparation Containing Pomegranate and Ginkgo Biloba for Anti-aging Activities
- ClinicalTrials.gov ID
- NCT03772418
- Acronym / sponsor ID
- AlAzharPGB
- Conditions
- Skin and Subcutaneous Tissue Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ahmed A. H. AbdellatifUniversity, hospital or other
- Study start
- 18 May 2018 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cream base | Placebo comparator | Drug: Cream BaseA group of volunteers receiving placebo medications without natural extracts of ginkgo biloba and Pomegranate. |
| Pomegrante and Ginkgo biloba group | Active comparator | Drug: Pomegrante and Ginkgo biloba groupA group of volunteers with the aging state receiving natural extracts of ginkgo biloba and Pomegranate in different topical dosage forms. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Insulin-dependent diabetes
- Hypertension disease
- Skin wound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cream BaseAlso: Aging group recieving placebo dosage formThe 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. | Drug | Cream base |
| Pomegrante and Ginkgo biloba groupAlso: Aging group receive ginkgo biloba and PomegranateThe 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). | Drug | Pomegrante and Ginkgo biloba group |
Primary outcome
Measurement of ant-aging activity of Pomegranate and Ginkgo biloba
Time frame: 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.
1 secondary outcome
Stable topical anti-aging products for long life shelf storage
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Background: PubMed 15171650Dong 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.
- Background: PubMed 28810554Kang 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 publication: PubMed 22615680Rasul 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Abdellatif, Ph.D. principal investigator
Assistant Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cream Base and Pomegrante and Ginkgo biloba group in people with Skin and Subcutaneous Tissue Disorders, run by Ahmed A. H. Abdellatif at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Saudi Arabia, Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed AH Abdellatif, Ph.D. (+966507726856 ext. 2014, a.abdellatif@qu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of ant-aging activity of Pomegranate and Ginkgo biloba (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03772418, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.