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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bakuchiol | Experimental | Bakuchiol 0.5% applied to face twice daily |
|
| Retinol | Active Comparator | 0.5% retinol applied to face nightly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bakuchiol | Drug | This group will receive bakuchiol |
|
|
| 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 |
| 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. |
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Inclusion Criteria:
• Individuals aged 30-55
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raja Sivamani, MD | UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Department of Dermatology | Sacramento | California | 95816 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bakuchiol | Bakuchiol 0.5% applied to face twice daily Bakuchiol: This group will receive bakuchiol |
| FG001 | Retinol | 0.5% retinol applied to face nightly Retinol: This group will receive retinol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Bakuchiol 21 participants were analyzed Retinol 23 participants were analyzed
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| ID | Title | Description |
|---|---|---|
| BG000 | Bakuchiol | Bakuchiol 0.5% applied to face twice daily Bakuchiol: This group will receive bakuchiol |
| BG001 | Retinol | 0.5% retinol applied to face nightly Retinol: This group will receive retinol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 21 participants were analyzed in the Bakuchiol group and 23 participants were analyzed in the Retinol group. | Posted | Number | percentage of reduced fine wrinkles | 12 week |
|
12 weeks
Subjects were no assessed for SAE or Mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bakuchiol | Bakuchiol 0.5% applied to face twice daily Bakuchiol: This group will receive bakuchiol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Iryna Rybak | UC Davis Dermatology | 916-551-2636 | irybak@ucdavis.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2017 | Aug 31, 2021 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 7, 2017 | Aug 31, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C012765 | bakuchiol |
| D014801 | Vitamin A |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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Double blind randomized study comparing the effect of bakuchiol and retinoid
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| Retinol | Drug | This group will receive retinol |
|
|
| Number of Reports of Facial Erythema Assessment | Image analysis based assessment of facial erythema | week 4, week 8 and week 12 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | We did not include ethnicity data in this study. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Percentage of Participants With Change in Appearance of Skin Pigmentation | Assessed using image analysis based assessment of facial pigment | Pigmentation was assessed through clinical grading and through facial analysis of the surface area of involvement and overall pigment intensity. | Posted | Number | percentage of participants | 12 week |
|
|
|
| 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. | Posted | Number | reports | Assessed at Week 4, 8, and 12. |
|
|
|
| Secondary | Number of Reports of Facial Erythema Assessment | Image analysis based assessment of facial erythema | Posted | Number | reports | week 4, week 8 and week 12 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 21 |
| EG001 | Retinol | 0.5% retinol applied to face nightly Retinol: This group will receive retinol | 0 | 0 | 0 | 0 | 0 | 23 |
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| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |