Comparison of the Cosmetic Effects of Bakuchiol and Retinol

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.

• Bakuchiol (Drug), also known as Bakuchiol 0.5%: This group will receive bakuchiol
• Retinol (Drug), also known as Retinol %: This group will receive retinol

Primary outcomes

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

Secondary outcomes

• Number of Reports of Stinging, Burning, Itching [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.
• Number of Reports of Facial Erythema Assessment [week 4, week 8 and week 12]: Image analysis based assessment of facial erythema

Sex: All, ages: 30 Years to 55 Years, accepts healthy volunteers

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

Participant flow

Outcome results

• Change in Wrinkle Appearance (Primary), Number, percentage of reduced fine wrinkles: Bakuchiol 19.0; Retinol 23.2
• Percentage of Participants With Change in Appearance of Skin Pigmentation (Primary), Number, percentage of participants: Bakuchiol 59; Retinol 44
• Number of Reports of Stinging, Burning, Itching (Secondary), Number, reports: Bakuchiol 0; Retinol 0
• Number of Reports of Facial Erythema Assessment (Secondary), Number, reports: Bakuchiol 0; Retinol 0

Adverse events

Time frame: 12 weeks

• Study Protocol (PDF, 2017-08-31)
• Informed Consent Form (PDF, 2017-09-07)

• Raja Sivamani, MD, Principal investigator, UC Davis