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 : November 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|Skin Pigmentation||Other: Almond Oil Drug: Hydroquinone Topical||Phase 4|
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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||March 1, 2023|
|Estimated Study Completion Date :||August 1, 2023|
Experimental: Almond oil
Almond Oil Pressed Cold
Other: Almond Oil
Active Comparator: Hydroquinone
Hydroquinone 2% cream
Drug: Hydroquinone Topical
Hydroquinone 2% cream
Other Name: Hydroquinone
- Intensity of facial pigment [ Time Frame: 16 weeks ]Facial images will be obtained and analyzed with the BTBP image analysis system
- 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.
- 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
- 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).
- Subjective tolerability assessment [ Time Frame: 16 weeks ]A questionnaire that assesses for stinging, itching, and burning will be utilized.
- Intensity of facial pigment [ Time Frame: 8 weeks ]Facial images will be obtained and analyzed with the BTBP image analysis system
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
|Contact: Iryna Rybakfirstname.lastname@example.org|
|Contact: Alexis Carringtonemail@example.com|
|United States, California|
|UC Davis Department of Dermatology, Clinical Trials Unit||Recruiting|
|Sacramento, California, United States, 95816|
|Contact: Iryna Rybak, BS 916-551-2636 firstname.lastname@example.org|
|Contact: Alexis Carrington, MD 916-551-2636 email@example.com|
|Principal Investigator: Raja K Sivamani, M.D.|
|Principal Investigator:||Raja Sivamani, MD MS AP||UC Davis Dermatology|