Prospective Evaluation of Topical Almond Oil vs Hydroquinone

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, Davis

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Premenopausal women of Fitzpatrick skin types 3 to 6

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Almond Oil

    Other intervention

    Almond oil

  • Hydroquinone Topical

    Drug

    Hydroquinone 2% cream

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Almond oilExperimental treatment 1 intervention
Group B: HydroquinoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intensity of facial pigment

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

Time frame
16 weeks

Secondary outcomes

1

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

The skin microbiome will be analyzed to assess any changes after topical almond oil application, compared to the use of topical hydroquinone.

Time frame
16 weeks
2

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

The skin microbiome will be analyzed to assess the presence of species within the genus Cutibacteria, Staphyloccoccus, and Ralstonia

Time frame
16 weeks
3

Appearance of facial redness

The research team will quantify the presence of facial redness with a SkinColorCatch from Delfin Technologies. This will measure the RGB colors and average them from each participant for each of the visits. Skin pigment, including the presence of redness, will be measured using a SkinColorCatch from Delfin Technologies. This device shows the RGB Colors, CIE L\*a\*b\* and L\*c\*h\* color space coordinates when the device is applied to the skin.Included is the link to the device (http://www.truesystem.co.kr/product/pdf/SkinColorCatch%20Brochure%202016.pdf).

Time frame
16 weeks
4

Subjective tolerability assessment

A questionnaire that assesses for stinging, itching, and burning will be utilized.

Time frame
16 weeks

Other outcomes

Sponsors and contacts

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