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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Almond Oil vs Hydroquinone for Hyperpigmentation?

Research shows that hydroquinone is a highly effective treatment for hyperpigmentation, reducing the size and darkness of skin lesions. However, it can have safety concerns with long-term use, which is why alternatives like natural extracts are being explored. ^{1 2 3 4 5}

Is hydroquinone safe for treating hyperpigmentation?

Hydroquinone has been used for over 40 years to treat hyperpigmentation, but there are safety concerns due to potential side effects like skin irritation and long-term risks. Despite these concerns, no cases of cancer have been linked to its use, but it is important to use it under medical supervision. ^{2 6 7 8 9}

How does the treatment of almond oil and hydroquinone differ from other treatments for hyperpigmentation?

Almond oil is a natural alternative that may offer a gentler option compared to hydroquinone, which is a common but sometimes controversial treatment due to potential side effects. Hydroquinone is known for its effectiveness but can cause skin irritation, while almond oil is generally considered safer and may be preferred by those seeking a more natural approach. ^{2 7 8 10 11}

Research Team

Raja Sivamani, MD MS AP

Principal Investigator

UC Davis Dermatology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

The use of botanical extracts as topical skin-lightening agents for the improvement of skin pigmentation disorders. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Natural Cosmeceutical Ingredients for Hyperpigmentation. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[Therapy of melanin-induced pigment anomalies]. [2014]

4. Denmark pubmed.ncbi.nlm.nih.gov

Niacinamide and 12-hydroxystearic acid prevented benzo(a)pyrene and squalene peroxides induced hyperpigmentation in skin equivalent. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

An open-label study of the efficacy and tolerability of microencapsulated hydroquinone 4% and retinol 0.15% with antioxidants for the treatment of hyperpigmentation. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Hydroquinone for skin lightening: safety profile, duration of use and when should we stop? [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Safety and Efficacy of a Topical Formulation Containing Epidermal Growth Factor, Tranexamic Acid, Vitamin C, Arbutin, Niacinamide and Other Ingredients as Hydroquinone 4% Alternatives to Improve Hyperpigmentation: A Prospective, Randomized, Controlled Split Face Study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a novel multimodality hydroquinone-free skin brightener over six months. [2015]

9. England pubmed.ncbi.nlm.nih.gov

The safety of hydroquinone. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Investigator-Blinded Comparison of Two Topical Regimens in Fitzpatrick Skin Types III-VI With Moderate to Severe Facial Hyperpigmentation. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Retinoic acid and hydroquinone induce inverse expression patterns on cornified envelope-associated proteins: implication in skin irritation. [2016]