NCT05734703

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

February 9, 2023

Last Update Submit

February 9, 2023

Conditions

WrinkleSpot PigmentedLines Skin

Keywords

hemp extractcaffeineresveratrolthyme

Outcome Measures

Primary Outcomes (3)

  • dermal-epidermal juncton flattening

    Histologic appearance of dermal-epidermal flattening on 'before' and 'after' skin biopsies.

    90 days

  • elastic fiber attenuation

    Histologic appearance of elastic fiber attenuation in the dermis on 'before' and 'after' skin biopsies.

    90 days

  • denisty of collagen fiber network

    Histologic appearance of the density of the collagen fibers on 'before' and 'after' skin biopsies.

    90 days

Secondary Outcomes (2)

  • Glogau System: Wrinkle Severity Ranking

    90 days

  • Modified Fitzpatrick Wrinkle Scale

    90 days

Study Arms (1)

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.

Drug: Nutraceutical Topical

Interventions

Nutraceutical TopicalDRUG

Once daily application of the topical nutraceutical to two by two inch area of skin for 90 days.

Standard Topical Daily Dose

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laser Scalp and Hair Center

Clearwater, Florida, 33762, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 33169920RESULT

  • Costa 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.

    PMID: 36364354RESULT

  • Few 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.

    PMID: 35274096RESULT

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Gregory L Smith, MD

    Nex Therapeutics, LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory L Smith, MD

CONTACT

7278517972drsmith@nex-therapeutics.com

Kathy Anderson, MD

CONTACT

8137873180kathya@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: One group of 25 adults aged 50 or over.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigaor

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 21, 2023

Study Start

March 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)