WrinkleEarly Phase 1NCT05734703
Skin Rejuvenation With Topical Extract and Other Nutraceuticals
A Early Phase 1 study testing Nutraceutical Topical in people with Wrinkle and Spot Pigmented, run by Medical Life Care Planners, LLC at 1 site in United States.
Trial summary
Hemp extract has been shown in several pre-clinical and clinical studies to have anti-aging effects on the skin through anti-oxidant and anti-inflammatory effects, in addition resveratrol, thyme and caffeine have been shown to have anti-aging effects related to fibrillar collagen production and extracellular matrix… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Spot Pigmented, Lines Skin
- What is being tested?
- Nutraceutical Topical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Jun 2023
- Phase
- Early 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50 or over
- Glogau Wrinkle Severity Scale of either 3 or 4 on the area to be biopsied.
- Not on current anti-aging therapies used as an ingredient in the study topical.
Who cannot join
- Under age 50
- Glogau Wrinkle Severity Scale of either 1 or 2 on the area to be biopsied.
- Currently using anti-aging therapies used as an ingredient in the study topical.
- Contraindication to performing skin shave biopsies in the area to be biopsied.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Laser Scalp and Hair Center
Clearwater, Florida, 33762
Kathy Anderson, MD, 813-787-3180, drsmith@nex-therapeutics.com
About this study
Official title: Skin Rejuvenation Using Topical Hemp-based Extract and Other Nutraceuticals
Hemp extract has been shown in several pre-clinical and clinical studies to have anti-aging effects on the skin through anti-oxidant and anti-inflammatory effects, in addition resveratrol, thyme and caffeine have been shown to have anti-aging effects related to fibrillar collagen production and extracellular matrix production in the dermis.
A combination of these four ingredients will be used in a vehicle of fermented medium chain triglyceride oil and skin shave biopsies will be taken before and after 90 days use of the topical to look for objective evidence of anti-aging effects in the dermis and epidermis.
Read the detailed description
The study is a case series of 25 adults over age 50 identified through social media outreach in the Tampa Bay area. Each subject will be given a topical serum and advised to apply it once daily to the specific two by two inch area of skin under study (forearm or back of the neck). The serum will be comprised of hemp-extract, resveratrol, caffeine, thyme oil and fermented medium chain triglyceride as a vehicle. The skin anti-aging serum is expected to contain hemp-extract 5%, caffeine 2%, Thyme essential oil 2% and resveratrol 0.5%. The subjects will use the test formulation for 90 days. The subjects will jhave shaved skin biopsies taken on either the forearm or back of the neck. The biopsies will be done on day zero and on day 90.
None of the subjects are currently using anti-aging therapies. No other anti-aging therapy will be used during the 90 days of the research.
The subjects will be advised to apply a thin layer of the serum once each night at bedtime. To the area of skin under study (forearm or back of the neck). The one-ounce bottle of serum is expected to last for the entire 90 days of the study. The subjects will be reminded each day via text messaging to use the product and each subject will be required to text back that the daily treatment has been applied.
The 'before and after' shaved biopsies will be independently evaluated by Dr. Michael Morgan, board certified Dermatopathologist at KorPath, Inc. He will perform hematoxylin and eosin (H\&E) staining, for histological analysis for morphology of the dermis and epidermis and histochemical staining for collagen and matrix analysis.
The subjects will be independently clinically evaluated by Dr. Kathy Anderson, board certified Dermatologist. She will determine "before and after" skin wrinkling scores using standard recognized metrics.
Each subject will have a diary app added to their smart phones to document daily use and potential adverse effects.
The results will be statistically evaluated with a standard for comparison. Study results with a p-value less than 0.05 will be determined to be statistically significant and the result will be evaluated for efficiency compared to generally recognized therapies
. The study will be prepared in standard fashion and submitted to recognized peer-review medical journals.
- Conditions
- Wrinkle, Spot Pigmented, Lines Skin
- Being tested
- Nutraceutical Topical
- Keywords
- hemp extract, caffeine, resveratrol, thyme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutraceutical TopicalDrug
Once daily application of the topical nutraceutical to two by two inch area of skin for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Standard Topical Daily Dose | Experimental | Only one arm in the study. Subjects treated with the topical daily for 90 days. The comparison will be 'before' and 'after' treatment skin biopsy results. Receives: Drug: Nutraceutical Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
dermal-epidermal juncton flattening
Histologic appearance of dermal-epidermal flattening on 'before' and 'after' skin biopsies.
Measured: 90 days
elastic fiber attenuation
Histologic appearance of elastic fiber attenuation in the dermis on 'before' and 'after' skin biopsies.
Measured: 90 days
denisty of collagen fiber network
Histologic appearance of the density of the collagen fibers on 'before' and 'after' skin biopsies.
Measured: 90 days
Secondary outcomes (2)
Glogau System: Wrinkle Severity Ranking
Glogau System: Wrinkle Severity Ranking score from 1-4 on 'before' and 'after' dermatologist physical examination of treated area
Measured: 90 days
Modified Fitzpatrick Wrinkle Scale
Modified Fitzpatrick Wrinkle Scale from class 0-2.5 on 'before' and 'after' dermatologist physical examination of treated area
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (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 WrinkleStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group of 25 adults aged 50 or over.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Life Care Planners, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory L Smith, MD, MPH, Medical Life Care Planners, LLC
- Investigators
- Gregory L Smith, MD, Principal investigator, Nex Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734703
- Sponsor's protocol ID
- Skin Antiaging Effects
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caverzan J, Mussi L, Sufi B, Padovani G, Nazato L, Camargo FB Junior, Magalhaes WV, Di Stasi LC. A new phytocosmetic preparation from Thymus vulgaris stimulates adipogenesis and controls skin aging process: In vitro studies and topical effects in a double-blind placebo-controlled clinical trial. J Cosmet Dermatol. 2021 Jul;20(7):2190-2202. doi: 10.1111/jocd.13818. Epub 2020 Nov 10.
PubMed 33169920Costa EF, Magalhaes WV, Di Stasi LC. Recent Advances in Herbal-Derived Products with Skin Anti-Aging Properties and Cosmetic Applications. Molecules. 2022 Nov 3;27(21):7518. doi: 10.3390/molecules27217518.
PubMed 36364354Few J, Lee MJ, Semersky A, Mariscal E, Vachon G. A Single-Center Study Evaluating the Effects of a Novel Retinol and Cannabidiol Combination Topical on Facial Skin. Aesthet Surg J Open Forum. 2022 Jan 27;4:ojac002. doi: 10.1093/asjof/ojac002. eCollection 2022.
PubMed 35274096
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Rejuvenation Using Topical Hemp-based Extract and Other Nutraceuticals
- ClinicalTrials.gov ID
- NCT05734703
- Acronym / sponsor ID
- Skin Antiaging Effects
- Conditions
- Wrinkle, Spot Pigmented, Lines Skin
- Keywords
- hemp extract, caffeine, resveratrol, thyme
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Medical Life Care Planners, LLCUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 21 Feb 2023 (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.
Hemp extract has been shown in several pre-clinical and clinical studies to have anti-aging effects on the skin through anti-oxidant and anti-inflammatory effects, in addition resveratrol, thyme and caffeine have been shown to have anti-aging effects related to fibrillar collagen production and extracellular matrix production in the dermis.
A combination of these four ingredients will be used in a vehicle of fermented medium chain triglyceride oil and skin shave biopsies will be taken before and after 90 days use of the topical to look for objective evidence of anti-aging effects in the dermis and epidermis.
Detailed description
The study is a case series of 25 adults over age 50 identified through social media outreach in the Tampa Bay area. Each subject will be given a topical serum and advised to apply it once daily to the specific two by two inch area of skin under study (forearm or back of the neck). The serum will be comprised of hemp-extract, resveratrol, caffeine, thyme oil and fermented medium chain triglyceride as a vehicle. The skin anti-aging serum is expected to contain hemp-extract 5%, caffeine 2%, Thyme essential oil 2% and resveratrol 0.5%. The subjects will use the test formulation for 90 days. The subjects will jhave shaved skin biopsies taken on either the forearm or back of the neck. The biopsies will be done on day zero and on day 90.
None of the subjects are currently using anti-aging therapies. No other anti-aging therapy will be used during the 90 days of the research.
The subjects will be advised to apply a thin layer of the serum once each night at bedtime. To the area of skin under study (forearm or back of the neck). The one-ounce bottle of serum is expected to last for the entire 90 days of the study. The subjects will be reminded each day via text messaging to use the product and each subject will be required to text back that the daily treatment has been applied.
The 'before and after' shaved biopsies will be independently evaluated by Dr. Michael Morgan, board certified Dermatopathologist at KorPath, Inc. He will perform hematoxylin and eosin (H\&E) staining, for histological analysis for morphology of the dermis and epidermis and histochemical staining for collagen and matrix analysis.
The subjects will be independently clinically evaluated by Dr. Kathy Anderson, board certified Dermatologist. She will determine "before and after" skin wrinkling scores using standard recognized metrics.
Each subject will have a diary app added to their smart phones to document daily use and potential adverse effects.
The results will be statistically evaluated with a standard for comparison. Study results with a p-value less than 0.05 will be determined to be statistically significant and the result will be evaluated for efficiency compared to generally recognized therapies
. The study will be prepared in standard fashion and submitted to recognized peer-review medical journals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group of 25 adults aged 50 or over.
| Arm | Type | Receives |
|---|---|---|
| Standard Topical Daily Dose | Experimental | Drug: Nutraceutical TopicalOnly one arm in the study. Subjects treated with the topical daily for 90 days. The comparison will be 'before' and 'after' treatment skin biopsy results. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50 or over
- Glogau Wrinkle Severity Scale of either 3 or 4 on the area to be biopsied.
- Not on current anti-aging therapies used as an ingredient in the study topical.
Key exclusion criteria (4 listed)
- Under age 50
- Glogau Wrinkle Severity Scale of either 1 or 2 on the area to be biopsied.
- Currently using anti-aging therapies used as an ingredient in the study topical.
- Contraindication to performing skin shave biopsies in the area to be biopsied.
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 |
|---|---|---|
| Nutraceutical TopicalOnce daily application of the topical nutraceutical to two by two inch area of skin for 90 days. | Drug | Standard Topical Daily Dose |
Primary outcome
dermal-epidermal juncton flattening
Time frame: 90 days
Histologic appearance of dermal-epidermal flattening on 'before' and 'after' skin biopsies.
elastic fiber attenuation
Time frame: 90 days
Histologic appearance of elastic fiber attenuation in the dermis on 'before' and 'after' skin biopsies.
denisty of collagen fiber network
Time frame: 90 days
Histologic appearance of the density of the collagen fibers on 'before' and 'after' skin biopsies.
2 secondary outcomes
Glogau System: Wrinkle Severity Ranking
Time frame: 90 days
Modified Fitzpatrick Wrinkle Scale
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Results publication: PubMed 33169920Caverzan J, Mussi L, Sufi B, Padovani G, Nazato L, Camargo FB Junior, Magalhaes WV, Di Stasi LC. A new phytocosmetic preparation from Thymus vulgaris stimulates adipogenesis and controls skin aging process: In vitro studies and topical effects in a double-blind placebo-controlled clinical trial. J Cosmet Dermatol. 2021 Jul;20(7):2190-2202. doi: 10.1111/jocd.13818. Epub 2020 Nov 10.
- Results publication: PubMed 36364354Costa EF, Magalhaes WV, Di Stasi LC. Recent Advances in Herbal-Derived Products with Skin Anti-Aging Properties and Cosmetic Applications. Molecules. 2022 Nov 3;27(21):7518. doi: 10.3390/molecules27217518.
- Results publication: PubMed 35274096Few J, Lee MJ, Semersky A, Mariscal E, Vachon G. A Single-Center Study Evaluating the Effects of a Novel Retinol and Cannabidiol Combination Topical on Facial Skin. Aesthet Surg J Open Forum. 2022 Jan 27;4:ojac002. doi: 10.1093/asjof/ojac002. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Gregory L Smith, MD principal investigator
Nex Therapeutics, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nutraceutical Topical in people with Wrinkle and Spot Pigmented, run by Medical Life Care Planners, LLC at 1 site in United States.
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 3 inclusion and 4 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Gregory L Smith, MD (7278517972, drsmith@nex-therapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dermal-epidermal juncton flattening (time frame: 90 days). The study lists 3 primary outcomes in all. 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 NCT05734703, 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 21 Feb 2023.