Wrinkle, Photoaging
Conditions
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.
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.
Interventions
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Double blind randomized study comparing the effect of bakuchiol and retinoid
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bakuchiol Bakuchiol 0.5% applied to face twice daily
Bakuchiol: This group will receive bakuchiol | 21 |
| Retinol 0.5% retinol applied to face nightly
Retinol: This group will receive retinol | 23 |
| Total | 44 |
Baseline characteristics
| Characteristic | Bakuchiol | Retinol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 23 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 23 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 21 participants | 23 participants | 44 participants |
| Sex: Female, Male Female | 19 Participants | 22 Participants | 41 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 21 | 0 / 23 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: 21 participants were analyzed in the Bakuchiol group and 23 participants were analyzed in the Retinol group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bakuchiol | Change in Wrinkle Appearance | 19.0 percentage of reduced fine wrinkles |
| Retinol | Change in Wrinkle Appearance | 23.2 percentage of reduced fine wrinkles |
Primary
Percentage of Participants With Change in Appearance of Skin Pigmentation
Assessed using image analysis based assessment of facial pigment
Time frame: 12 week
Population: Pigmentation was assessed through clinical grading and through facial analysis of the surface area of involvement and overall pigment intensity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bakuchiol | Percentage of Participants With Change in Appearance of Skin Pigmentation | 59 percentage of participants |
| Retinol | Percentage of Participants With Change in Appearance of Skin Pigmentation | 44 percentage of participants |
Secondary
Number of Reports of Facial Erythema Assessment
Image analysis based assessment of facial erythema
Time frame: week 4, week 8 and week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bakuchiol | Number of Reports of Facial Erythema Assessment | 0 reports |
| Retinol | Number of Reports of Facial Erythema Assessment | 0 reports |
Secondary
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bakuchiol | Number of Reports of Stinging, Burning, Itching | 0 reports |
| Retinol | Number of Reports of Stinging, Burning, Itching | 0 reports |