Comparison of the Cosmetic Effects of Bakuchiol and Retinol

Early Phase 1CompletedNCT03112863

University of California, Davis44 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Wrinkle Photoaging

Interventions

BakuchiolDRUG

This group will receive bakuchiol

RetinolDRUG

This group will receive retinol

Eligibility

Sex: ALLMin age: 30 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UC Davis Department of Dermatology

Sacramento, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 week

Percentage of Participants With Change in Appearance of Skin Pigmentation

Assessed using image analysis based assessment of facial pigment

Time frame: 12 week

Secondary Outcomes

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.

Time frame: Assessed at Week 4, 8, and 12.

Number of Reports of Facial Erythema Assessment

Image analysis based assessment of facial erythema

Time frame: week 4, week 8 and week 12

Data from ClinicalTrials.gov

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