Almond oil versus 2% hydroquinone for facial pigmentation
Prospective Evaluation of Topical Almond Oil vs Hydroquinone on the Appearance of Facial Pigmentation and the Stability of the Microbiome
This test compares nightly almond oil and 2% hydroquinone to see which better reduces facial pigmentation in premenopausal women with Fitzpatrick skin types 3–6.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT04875715 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label comparison enrolling 50 premenopausal women with Fitzpatrick skin types 3–6, with 25 assigned to nightly almond oil and 25 to nightly 2% hydroquinone for four months. Investigators will collect facial images and measure skin pigment, skin hydration, and sebum excretion rate at baseline and follow-up visits. The study will also analyze changes in the facial skin microbiome associated with each topical treatment. All visits take place at the UC Davis Department of Dermatology Clinical Trials Unit.
Who should consider this trial
Good fit: Premenopausal women with Fitzpatrick skin types 3–6 who are not allergic to nuts and can attend in-person visits at UC Davis are ideal candidates.
Not a fit: People with nut allergies, current smokers or heavy former smokers, those on unstable hormonal therapies, or those who had recent facial cosmetic procedures are unlikely to qualify and may not benefit from the interventions tested.
Why it matters
Potential benefit: If successful, the study could identify a gentler, natural topical option that reduces facial pigmentation and favorably influences the skin microbiome.
How similar studies have performed: Hydroquinone is a well-established treatment for hyperpigmentation, whereas using topical almond oil for pigment reduction and microbiome changes is largely novel with limited clinical evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sacramento, California
- UC Davis Department of Dermatology, Clinical Trials Unit — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Raja Sivamani, MD MS AP — UC Davis Dermatology
- Study coordinator: Iryna Rybak
- Email: irybak@ucdavis.edu
- Phone: 916-551-2636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.