NCT05011461

Brief Summary

The purpose of this experiment is to analyze wrinkle severity, the skin barrier and facial pigmentation level after topical almond oil application, compared to the use of topical retinol. Both the almond oil and the 0.5% topical retinol studied is investigational.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 17, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

August 16, 2021

Last Update Submit

February 12, 2023

Conditions

WrinklesSkin

Outcome Measures

Primary Outcomes (1)

  • Appearance of wrinkle severity

    Facial wrinkles will be assessed with the use of a validated high resolution facial modeling system. The high-resolution facial modeling system will be performed with the 3D Clarity Pro® Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA) and will specifically assess for wrinkle severity and wrinkle length as was performed in the previous pilot study.

    12-weeks

Secondary Outcomes (3)

  • Appearance of facial color tone and evenness

    12-weeks

  • Appearance of facial redness

    12-weeks

  • Subjective tolerability

    12-weeks

Study Arms (2)

Almond Oil

EXPERIMENTAL

Almond Oil Pressed Cold

Other: Almond Oil

Topical Retinol

ACTIVE COMPARATOR

Retinol Lotion 0.5%

Other: Almond Oil

Interventions

Almond OilOTHER

Almond Oil Pressed Cold

Almond OilTopical Retinol

Eligibility Criteria

Age40 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal women of Fitzpatrick skin types 1 and 2

You may not qualify if:

  • Those with a nut allergy
  • Smoking is an independent risk factor and serves as a confounder for the development of facial wrinkles and photoaging \[14\]. Therefore, current smokers, those that have smoked within the past year, and former smokers with greater than a 20-pack year history of smoking will be excluded.
  • Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehlers-Danlos syndromes) will be excluded as this can be a confounder for facial wrinkles.
  • Those who have undergone any cosmetic procedures to the face in the 4 months prior to enrollment in the opinion of the investigator. People that have undergone deeper chemical peels (TCA based peels) within 1 year prior to enrollment will also not be eligible.
  • Individuals who are unwilling to discontinue vitamin E food sources during the washout and intervention. This includes
  • Vitamin E containing supplements.
  • Sunflower seeds or sunflower oil.
  • All nuts.
  • Individual who are unwilling to discontinue topical cosmetic products during the duration of the study or unwilling to undergo a 2-week washout of topicals that are known to modulate collagen and pigment:
  • Retinoids such as tretinoin, adapalene, retinol, except as provided by the study.
  • Antioxidant ingredients such as vitamin C or vitamin E.
  • Pigment reducing agents such as hydroquinone, a retinoid, azelaic acid, kojic acid, pomegranate seed oil, and other similar agents per the discretion of the investigator, except for the retinol that is provided in this study.
  • Topicals that contain a nut oil or nut extract as part of their ingredient list.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Department of Dermatology, Clinical Trials Unit

Sacramento, California, 95816, United States

Location

MeSH Terms

Interventions

almond oil

Study Officials

  • Raja Sivamani, M.D.

    UC Davis Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Dermatology

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 18, 2021

Study Start

May 17, 2021

Primary Completion

October 5, 2022

Study Completion

October 5, 2022

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)