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Comparison of the Cosmetic Effects of Bakuchiol and Retinol

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ClinicalTrials.gov Identifier: NCT03112863
Recruitment Status : Active, not recruiting
First Posted : April 13, 2017
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
Subjects will be assigned to a retinoid cream or bakuchiol to compare the cosmetic effects. This will take place over a 12 week period.

Condition or disease Intervention/treatment Phase
Wrinkle Photoaging Drug: Bakuchiol Drug: Retinol Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized study comparing the effect of bakuchiol and retinoid
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Cosmetic Effects of Bakuchiol and Retinol
Actual Study Start Date : March 24, 2017
Estimated Primary Completion Date : March 2027
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics Vitamin A

Arm Intervention/treatment
Experimental: Bakuchiol Drug: Bakuchiol
This group will receive bakuchiol

Active Comparator: Retinol Drug: Retinol
This group will receive retinol




Primary Outcome Measures :
  1. Change in wrinkle appearance [ Time Frame: 12 week ]
    Assessed using image analysis based assessment of wrinkle severity (depth and length)

  2. Change in appearance of skin pigmentation [ Time Frame: 12 week ]
    Assessed using image analysis based assessment of facial pigment


Secondary Outcome Measures :
  1. Subjective Tolerability Assessment [ Time Frame: Assessed at Week 4, 8, and 12. ]
    Subjective tolerability assessment of stinging, burning, itching

  2. Facial Erythema Assessment [ Time Frame: week 4, week 8 and week 12 ]
    Image analysis based assessment of facial erythema

  3. Change in appearance of skin pigmentation [ Time Frame: week 4 and week 8 ]
    Assessed using image analysis based assessment of facial pigment

  4. Change in wrinkle appearance [ Time Frame: week 4 and week 8 ]
    Assessed using image analysis based assessment of wrinkle severity (depth and length)

  5. Clinical assessment of facial redness [ Time Frame: week 0, week 4, week 8, and week 12 ]
    dermatologist based assessment of redness at each visit based on Likert scale

  6. Clinical assessment of facial scaling [ Time Frame: week 0, week 4, week 8, and week 12 ]
    dermatologist based assessment of scaling at each visit based on Likert scale

  7. Clinical assessment of facial hyperpigmentation [ Time Frame: week 0, week 4, week 8, and week 12 ]
    dermatologist based assessment of facial hyperpigmentation at each visit based on Likert scale



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• Individuals aged 30-55

Exclusion Criteria:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant or breast feeding women
  • Prisoners
  • Those with acne, eczema, seborrheic dermatitis, rosacea or polycystic ovarian syndrome
  • Those who have used isotretinoin in the last 6 months
  • Those who have used products containing salicylic acid, beta hydroxyl acids or vitamins A, C, or E in the last 14 days
  • Those who have used topical antibiotics or topical retinoids in the last 30 days
  • Those who are currently smoking or have smoked within the past 3 years.
  • Those who have had a recent surgical or cosmetic procedure in the last 3 months that can affect facial wrinkles or facial hyperpigmentation, such as botulinum toxin injections, chemical peels, laser based therapies to the face, or face lift surgeries

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): NCT03112863


Locations
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United States, California
UC Davis Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Raja Sivamani, MD UC Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03112863    
Other Study ID Numbers: 1015536
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin A
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs