NCT04875715

Brief Summary

The purpose of this study is to analyze facial pigmentation and skin microbiome changes after topical almond oil application, compared to the use of topical hydroquinone.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
3mo left

Started Jul 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress95%
Jul 2021Aug 2026

First Submitted

Initial submission to the registry

March 5, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

5.1 years

First QC Date

March 5, 2021

Last Update Submit

September 10, 2025

Conditions

Skin Pigmentation

Outcome Measures

Primary Outcomes (1)

  • Intensity of facial pigment

    Facial images will be obtained and analyzed with the BTBP image analysis system

    16 weeks

Secondary Outcomes (5)

  • Shifts in the microbiome diversity (Shannon index as an example)

    16 weeks

  • Quantification for the presence of species within the genus Cutibacteria, Staphyloccoccus, and Ralstonia

    16 weeks

  • Appearance of facial redness

    16 weeks

  • Subjective tolerability assessment

    16 weeks

  • Intensity of facial pigment

    8 weeks

Study Arms (2)

Almond oil

EXPERIMENTAL

Almond Oil Pressed Cold

Other: Almond Oil

Hydroquinone

ACTIVE COMPARATOR

Hydroquinone 2% cream

Drug: Hydroquinone Topical

Interventions

Almond OilOTHER

Almond oil

Almond oil
Hydroquinone TopicalDRUG

Hydroquinone 2% cream

Also known as: Hydroquinone
Hydroquinone

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPremenopausal women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Premenopausal women of Fitzpatrick skin types 3 to 6

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 aging \[18\]. 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 syndrome) will be excluded as this can be a confounder for facial photoaging.
  • Hormonal medications or therapies will not be allowed unless they have been stable on their medications for at least 2 months. Examples include oral contraceptives, progesterone-based injections, and estrogen based hormonal replacement therapy.
  • 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 containing supplements and food sources during the washout and intervention.
  • Individual who are unwilling to discontinue topical cosmetic products during the duration of the study.
  • Individuals who are not willing to engage in a two-week washout on topical treatments known to affect facial pigmentation and these agents will be restricted during the study period as well. These include topicals that contain:
  • Retinoids such as tretinoin, adapalene, retinol.
  • Antioxidant ingredients such as vitamin C or vitamin E.
  • Pigment-reducing agents such as hydroquinone, azelaic acid, kojic acid per the discretion of the investigator except for the hydroquinone that is provided in this study.
  • Topicals that contain a nut oil or nut extract as part of their ingredient list.
  • Furthermore, subjects will be asked to refrain from use of any other topical products for one week prior to each visit apart from the study agents supplied from this study.

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

RECRUITING

Related Links

MeSH Terms

Conditions

Pigmentation Disorders

Interventions

almond oilhydroquinone

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Raja Sivamani, MD MS AP

    UC Davis Dermatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Iryna Rybak

CONTACT

916-551-2636irybak@ucdavis.edu

Alexis Carrington

CONTACT

aecarrington@ucdavis.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

May 6, 2021

Study Start

July 1, 2021

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)