WrinkleEarly Phase 1NCT03112863
Comparison of the Cosmetic Effects of Bakuchiol and Retinol
A Early Phase 1 study testing Bakuchiol and Retinol in people with Wrinkle and Photoaging, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Photoaging
- What is being tested?
- Bakuchiol and Retinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2017to 1 Mar 2019
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals aged 30-55
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Department of Dermatology
Sacramento, California, 95816
About this study
Subjects will be assigned to a retinoid cream or bakuchiol to compare the cosmetic effects. This will take place over a 12 week period.
Read the 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.
- Conditions
- Wrinkle, Photoaging
- Being tested
- Bakuchiol, Retinol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BakuchiolDrug
Also called Bakuchiol 0.5%
This group will receive bakuchiol
RetinolDrug
Also called Retinol %
This group will receive retinol
| Study group | Role | What they receive |
|---|---|---|
| Bakuchiol | Experimental | Bakuchiol 0.5% applied to face twice daily Receives: Drug: Bakuchiol |
| Retinol | Active comparator | 0.5% retinol applied to face nightly Receives: Drug: Retinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 week
Percentage of Participants With Change in Appearance of Skin Pigmentation
Assessed using image analysis based assessment of facial pigment
Measured: 12 week
Secondary outcomes (2)
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.
Measured: Assessed at Week 4, 8, and 12.
Number of Reports of Facial Erythema Assessment
Image analysis based assessment of facial erythema
Measured: week 4, week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start24 Mar 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WrinkleStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized study comparing the effect of bakuchiol and retinoid
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raja Sivamani, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112863
- Sponsor's protocol ID
- 1015536
- Status last verified
- Oct 2021
- First submitted
- 27 Mar 2017
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Cosmetic Effects of Bakuchiol and Retinol
- ClinicalTrials.gov ID
- NCT03112863
- Acronym / sponsor ID
- 1015536
- Conditions
- Wrinkle, Photoaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Posted 2 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized study comparing the effect of bakuchiol and retinoid
| Arm | Type | Receives |
|---|---|---|
| Bakuchiol | Experimental | Drug: BakuchiolBakuchiol 0.5% applied to face twice daily |
| Retinol | Active comparator | Drug: Retinol0.5% retinol applied to face nightly |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals aged 30-55
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BakuchiolAlso: Bakuchiol 0.5%This group will receive bakuchiol | Drug | Bakuchiol |
| RetinolAlso: Retinol %This group will receive retinol | Drug | Retinol |
Primary outcome
Change in Wrinkle Appearance
Time frame: 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
Time frame: 12 week
Assessed using image analysis based assessment of facial pigment
2 secondary outcomes
Number of Reports of Stinging, Burning, Itching
Time frame: Assessed at Week 4, 8, and 12.
Number of Reports of Facial Erythema Assessment
Time frame: week 4, week 8 and week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Wrinkle
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Skin Laxity, Wrinkle
Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja Sivamani, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bakuchiol and Retinol in people with Wrinkle and Photoaging, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Wrinkle Appearance (time frame: 12 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.