Almond Oil vs Hydroquinone for Hyperpigmentation

Overseen By Alexis Carrington

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of California, Davis

Must not be taking: Hormonal medications

Disqualifiers: Nut allergy, Smoking, Autoimmune conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effects of almond oil and hydroquinone topical (a skin-lightening agent) on facial hyperpigmentation (dark spots) and the skin's microbiome (natural bacteria). Researchers seek to understand how these treatments impact skin appearance and health. The trial is suitable for premenopausal women with medium to dark skin tones (Fitzpatrick skin types 3 to 6) who do not have a nut allergy and are not using certain skin products or medications. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, providing an opportunity to explore its benefits for more patients.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain topical treatments that affect facial pigmentation for two weeks before starting the study. Hormonal medications are allowed if they have been stable for at least two months. Participants must also stop using vitamin E supplements and certain topical cosmetic products during the study.

What is the safety track record for these treatments?

Research shows that both almond oil and hydroquinone are generally safe for skin use, but they have different safety considerations.

Almond oil is widely used in skincare and is considered safe for skin application, with no major side effects reported. Most people tolerate it well.

Hydroquinone creams, containing 2% to 5% of the ingredient, effectively treat dark spots. However, they can cause side effects like skin irritation or, rarely, a condition called ochronosis, which leads to skin darkening. Careful adherence to recommended guidelines is important for long-term use.

Both treatments have been well-researched. Almond oil has a strong safety record, while hydroquinone is effective but carries some potential risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for hyperpigmentation, which often involve chemical agents like hydroquinone, almond oil offers a natural alternative. Almond oil is unique because it is derived from pressed cold almonds, which are known for their gentle skin-nourishing properties. Researchers are excited about almond oil as it might reduce hyperpigmentation with fewer side effects, appealing to those seeking less harsh skincare solutions. Additionally, almond oil provides a moisturizing benefit, which could enhance skin health overall, setting it apart from traditional depigmenting creams.

What evidence suggests that this trial's treatments could be effective for hyperpigmentation?

Research has shown that topical hydroquinone effectively treats dark spots on the skin. Studies have found that a 2% concentration of hydroquinone, which participants in this trial may receive, works well for these conditions. Although stronger concentrations might be more effective, they can also cause more side effects. In contrast, no scientific evidence supports almond oil, another treatment option in this trial, in reducing dark spots. While some natural products are under study for skin discoloration, sweet almond oil has not proven effective for this purpose. ^{3 4 6 7 8}

Who Is on the Research Team?

Raja Sivamani, MD MS AP

Principal Investigator

UC Davis Dermatology

Are You a Good Fit for This Trial?

This trial is for premenopausal women with medium to dark skin (Fitzpatrick types 3-6) who haven't smoked in the past year. They shouldn't have nut allergies, autoimmune photosensitive conditions, or collagen production disorders. Participants must not have had facial cosmetic procedures in the last 4 months and agree to stop using certain skincare products.

Inclusion Criteria

Premenopausal women of Fitzpatrick skin types 3 to 6

Exclusion Criteria

Current smokers, those that have smoked within the past year, and former smokers with greater than a 20 pack year history of smoking

Hormonal medications or therapies unless stable on their medications for at least 2 months

You have an allergy to nuts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either almond oil or 2% hydroquinone nightly for facial pigmentation and microbiome analysis

16 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Almond Oil
• Hydroquinone Topical

Trial Overview The study compares almond oil's effects on facial pigmentation and skin microbiome changes against hydroquinone, a known pigment-reducing agent. Women will use either almond oil or hydroquinone topically on their face to see which one works better for hyperpigmentation.

How Is the Trial Designed?

Group I: Almond oil Experimental Treatment 1 Intervention

Almond Oil Pressed Cold

Group II: Hydroquinone Active Control 1 Intervention

Hydroquinone 2% cream

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10297259/

The Efficacy of Regeneration Oil and Almond Oil on Split ... Regeneration oil and control oil presented comparable results regarding scar quality, itchiness and colorit in healed split-thickness skin graft donor sites.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05011461

The Effect of Topical Almond Oil vs. Topical Retinol on The ... The purpose of this experiment is to analyze wrinkle severity, the skin barrier and facial pigmentation level after topical almond oil application.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212429224014433

Anti-melanogenic effect of a novel oligosaccharide derived ... Abstract. The application of natural products for regulating skin pigmentation is increasingly being acknowledged due to their security and proven efficacy.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04875715

Prospective Evaluation of Topical Almond Oil vs ... 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 ...

5. us.typology.com us.typology.com/library/facial-care-sweet-almond-oil-to-erase-brown-spots

Is sweet almond oil effective against brown spots? To date, no scientific study has reported any beneficial effects of sweet almond oil when topically applied to reduce pigmentation spots.

6. cir-safety.org cir-safety.org/sites/default/files/RR_Sweet%20Almond.pdf

Safety Assessment of Prunus Amygdalus Dulcis (Sweet ... On the basis of the available data and clinical experience, it is concluded that Sweet Almond Oil and Almond Meal are safe for topical ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6916293/

Prospective randomized controlled pilot study on the ... Our randomized, investigator‐blinded clinical trial demonstrates that daily consumption of almonds significantly decreased wrinkle severity and wrinkle width in ...

8. researchgate.net researchgate.net/publication/349869215_Prospective_Randomized_Controlled_Trial_on_the_Effects_of_Almonds_on_Facial_Wrinkles_and_Pigmentation

Prospective Randomized Controlled Trial on the Effects of ... Facial pigment intensity was decreased 20% in the almond group at week 16 and this was maintained by week 24. There were no significant ...