Early Phase 1
N=44
Comparison of the Cosmetic Effects of Bakuchiol and Retinol
Wrinkle · Photoaging
Bottom Line
View on ClinicalTrials.gov: NCT03112863 ↗Enrolled (actual)
44
Serious AEs
—
Results posted
Nov 2021
Primary outcome: Primary: Change in Wrinkle Appearance — 19.0; 23.2 percentage of reduced fine wrinkles
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Bakuchiol (Drug); Retinol (Drug)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Wrinkle Appearance |
19.0; 23.2 | — |
| PRIMARY Percentage of Participants With Change in Appearance of Skin Pigmentation |
59; 44 | — |
| SECONDARY Number of Reports of Stinging, Burning, Itching |
0; 0 | — |
| SECONDARY Number of Reports of Facial Erythema Assessment |
0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03112863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.