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Prospective Evaluation of Topical Almond Oil vs Hydroquinone

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ClinicalTrials.gov Identifier: NCT04875715
Recruitment Status : Recruiting
First Posted : May 6, 2021
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Skin Pigmentation Other: Almond Oil Drug: Hydroquinone Topical Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective Evaluation of Topical Almond Oil vs Hydroquinone on the Appearance of Facial Pigmentation and the Stability of the Microbiome
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Almond oil
Almond Oil Pressed Cold
Other: Almond Oil
Almond oil

Active Comparator: Hydroquinone
Hydroquinone 2% cream
Drug: Hydroquinone Topical
Hydroquinone 2% cream
Other Name: Hydroquinone




Primary Outcome Measures :
  1. Intensity of facial pigment [ Time Frame: 16 weeks ]
    Facial images will be obtained and analyzed with the BTBP image analysis system


Secondary Outcome Measures :
  1. Shifts in the microbiome diversity (Shannon index as an example) [ Time Frame: 16 weeks ]
    The skin microbiome will be analyzed to assess any changes after topical almond oil application, compared to the use of topical hydroquinone.

  2. Quantification for the presence of species within the genus Cutibacteria, Staphyloccoccus, and Ralstonia [ Time Frame: 16 weeks ]
    The skin microbiome will be analyzed to assess the presence of species within the genus Cutibacteria, Staphyloccoccus, and Ralstonia

  3. Appearance of facial redness [ Time Frame: 16 weeks ]

    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).


  4. Subjective tolerability assessment [ Time Frame: 16 weeks ]
    A questionnaire that assesses for stinging, itching, and burning will be utilized.

  5. Intensity of facial pigment [ Time Frame: 8 weeks ]
    Facial images will be obtained and analyzed with the BTBP image analysis system



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Premenopausal women
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04875715


Contacts
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Contact: Iryna Rybak 916-551-2636 irybak@ucdavis.edu
Contact: Alexis Carrington aecarrington@ucdavis.edu

Locations
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United States, California
UC Davis Department of Dermatology, Clinical Trials Unit Recruiting
Sacramento, California, United States, 95816
Contact: Iryna Rybak, BS    916-551-2636    irybak@ucdavis.edu   
Contact: Alexis Carrington, MD    916-551-2636    aecarrington@ucdavis.edu   
Principal Investigator: Raja K Sivamani, M.D.         
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Raja Sivamani, MD MS AP UC Davis Dermatology
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04875715    
Other Study ID Numbers: 1666478
First Posted: May 6, 2021    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydroquinone
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents