Trial Outcomes & Findings for Comparison of the Cosmetic Effects of Bakuchiol and Retinol (NCT NCT03112863)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

44 participants

Primary outcome timeframe

12 week

Results posted on

2021-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Bakuchiol Bakuchiol 0.5% applied to face twice daily Bakuchiol: This group will receive bakuchiol	Retinol 0.5% retinol applied to face nightly Retinol: This group will receive retinol
Overall Study STARTED	21	23
Overall Study COMPLETED	21	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of the Cosmetic Effects of Bakuchiol and Retinol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bakuchiol n=21 Participants Bakuchiol 0.5% applied to face twice daily Bakuchiol: This group will receive bakuchiol	Retinol n=23 Participants 0.5% retinol applied to face nightly Retinol: This group will receive retinol	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	23 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 week

Population: 21 participants were analyzed in the Bakuchiol group and 23 participants were analyzed in the Retinol group.

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.

Outcome measures

Outcome measures
Measure	Bakuchiol n=21 Participants Bakuchiol 0.5% applied to face twice daily Bakuchiol: This group will receive bakuchiol	Retinol n=23 Participants 0.5% retinol applied to face nightly Retinol: This group will receive retinol
Change in Wrinkle Appearance	19.0 percentage of reduced fine wrinkles	23.2 percentage of reduced fine wrinkles

PRIMARY outcome

Timeframe: 12 week

Population: Pigmentation was assessed through clinical grading and through facial analysis of the surface area of involvement and overall pigment intensity.

Assessed using image analysis based assessment of facial pigment

Outcome measures

Outcome measures
Measure	Bakuchiol n=21 Participants Bakuchiol 0.5% applied to face twice daily Bakuchiol: This group will receive bakuchiol	Retinol n=23 Participants 0.5% retinol applied to face nightly Retinol: This group will receive retinol
Percentage of Participants With Change in Appearance of Skin Pigmentation	59 percentage of participants	44 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bakuchiol n=21 Participants Bakuchiol 0.5% applied to face twice daily Bakuchiol: This group will receive bakuchiol	Retinol n=23 Participants 0.5% retinol applied to face nightly Retinol: This group will receive retinol
Number of Reports of Stinging, Burning, Itching	0 reports	0 reports

SECONDARY outcome

Timeframe: week 4, week 8 and week 12

Image analysis based assessment of facial erythema

Outcome measures

Outcome measures
Measure	Bakuchiol n=21 Participants Bakuchiol 0.5% applied to face twice daily Bakuchiol: This group will receive bakuchiol	Retinol n=23 Participants 0.5% retinol applied to face nightly Retinol: This group will receive retinol
Number of Reports of Facial Erythema Assessment	0 reports	0 reports

Adverse Events

Bakuchiol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Retinol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Iryna Rybak

UC Davis Dermatology

Phone: 916-551-2636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place