Comparison of the Cosmetic Effects of Bakuchiol and Retinol

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

Study Overview

• Status: Completed
• Conditions: Wrinkle; Photoaging
• Intervention / Treatment: Drug: Bakuchiol; Drug: Retinol

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • UC Davis Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bakuchiol; Bakuchiol 0.5% applied to face twice daily	Drug: Bakuchiol; This group will receive bakuchiol; Other Names: Bakuchiol 0.5%
Active Comparator: Retinol; 0.5% retinol applied to face nightly	Drug: Retinol; This group will receive retinol; Other Names: Retinol %

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Wrinkle Appearance	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.	12 week
Percentage of Participants With Change in Appearance of Skin Pigmentation	Assessed using image analysis based assessment of facial pigment	12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Reports of Stinging, Burning, Itching	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.	Assessed at Week 4, 8, and 12.
Number of Reports of Facial Erythema Assessment	Image analysis based assessment of facial erythema	week 4, week 8 and week 12

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Raja Sivamani, MD, UC Davis

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Micronutrients; Vitamins; Antioxidants; Anticarcinogenic Agents; Vitamin A; Retinol palmitate
• Other Study ID Numbers: 1015536

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No