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Comparison of the Cosmetic Effects of Bakuchiol and Retinol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03112863
Recruitment Status : Completed
First Posted : April 13, 2017
Results First Posted : November 2, 2021
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
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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 Early Phase 1

Detailed Description:

Bakuchiol is a phytochemical that has demonstrated cutaneous antiageing effects when applied topically. Early studies have suggested that bakuchiol is a functional analogue of topical retinoids, as both compounds have been shown to induce similar gene expression in the skin and lead to improvement of cutaneous photodamage. No in vivo studies have compared the two compounds for efficacy and side-effects.

The aim of this study is to compare the cosmetic effects of Bakuchiol to Retinol over a 12-week period.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 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
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics Vitamin A

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bakuchiol
Bakuchiol 0.5% applied to face twice daily
 Drug: Bakuchiol
This group will receive bakuchiol
Other Name: Bakuchiol 0.5%
Active Comparator: Retinol
0.5% retinol applied to face nightly
 Drug: Retinol
This group will receive retinol
Other Name: Retinol %


Outcome Measures
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Primary Outcome Measures :
  1. Change in Wrinkle Appearance [ Time Frame: 12 week ]

    Assessed using image analysis based assessment of wrinkle severity (depth and length).

    The primary outcome measure was image-analysis-based assessment of wrinkle severity and pigmentation at 12 weeks.


  2. Percentage of Participants With Change in Appearance of Skin Pigmentation [ Time Frame: 12 week ]
    Assessed using image analysis based assessment of facial pigment


Secondary Outcome Measures :
  1. Number of Reports of Stinging, Burning, Itching [ Time Frame: Assessed at Week 4, 8, and 12. ]
    Subjective tolerability assessment of stinging, burning, itching. Secondary outcome measures included redness, participant-reported tolerability (itching, burning and stinging) and in-person clinical assessments (pigmentation, scaling and erythema) throughout the study.

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


Eligibility Criteria
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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
Contacts and Locations
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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
  Study Documents (Full-Text)

Documents provided by University of California, Davis:
Study Protocol  [PDF] August 31, 2017
Informed Consent Form  [PDF] September 7, 2017
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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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
Results First Posted: November 2, 2021
Last Update Posted: November 2, 2021
Last Verified: October 2021

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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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Vitamin A
Retinol palmitate
Vitamins
Micronutrients
Physiological Effects of Drugs
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents