Comparison of the Cosmetic Effects of Bakuchiol and Retinol

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

Detailed Description
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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.

Official Title
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Comparison of the Cosmetic Effects of Bakuchiol and Retinol

Conditions
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Wrinkle, Photoaging

Intervention / Treatment
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* Drug: Bakuchiol
* Drug: Retinol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomized study comparing the effect of bakuchiol and retinoid
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bakuchiol<br>Bakuchiol 0.5% applied to face twice daily | Drug: Bakuchiol<br>* This group will receive bakuchiol<br>* Other names: Bakuchiol 0.5%;|
| Active Comparator: Retinol<br>0.5% retinol applied to face nightly | Drug: Retinol<br>* This group will receive retinol<br>* Other names: Retinol %;|

What is the study measuring?
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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 |