Prospective Evaluation of Topical Almond Oil vs Hydroquinone

NCT ID: NCT04875715

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2026-08-01

Brief Summary

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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.

Detailed Description

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

There will be a total of 50 subjects:

* 25 randomized to receive almond oil nightly
* 25 randomized to receive 2% hydroquinone nightly

Study Timelines:

* The duration of an individual subject's participation will last from the day of the consent/screening (visit 1) until visit 5 where they will have images taken and measurements collected to assess skin pigment, skin hydration, sebum excretion rate.
* The duration of participation is 4 months.
* The estimated time for the investigators to complete primary analysis is 2 years.

Conditions

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Skin Pigmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Almond oil

Almond Oil Pressed Cold

Group Type EXPERIMENTAL

Almond Oil

Intervention Type OTHER

Almond oil

Hydroquinone

Hydroquinone 2% cream

Group Type ACTIVE_COMPARATOR

Hydroquinone Topical

Intervention Type DRUG

Hydroquinone 2% cream

Interventions

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Almond Oil

Almond oil

Intervention Type OTHER

Hydroquinone Topical

Hydroquinone 2% cream

Intervention Type DRUG

Other Intervention Names

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Hydroquinone

Eligibility Criteria

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Inclusion Criteria

* Premenopausal women of Fitzpatrick skin types 3 to 6

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raja Sivamani, MD MS AP

Role: PRINCIPAL_INVESTIGATOR

UC Davis Dermatology

Locations

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UC Davis Department of Dermatology, Clinical Trials Unit

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Iryna Rybak

Role: CONTACT

916-551-2636

Alexis Carrington

Role: CONTACT

Facility Contacts

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Iryna Rybak, BS

Role: primary

916-551-2636

Alexis Carrington, MD

Role: backup

916-551-2636

Related Links

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Other Identifiers

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1666478

Identifier Type: -

Identifier Source: org_study_id

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