Comparison of the Cosmetic Effects of Bakuchiol and Retinol

Wrinkle Clinical Trial

Official title:

Comparison of the Cosmetic Effects of Bakuchiol and Retinol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112863
• Other study ID #: 1015536
• Status: Completed
• Phase: Early Phase 1
• Start date: March 24, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: October 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Photoaging
• Wrinkle

Intervention

Drug:
• Bakuchiol
This group will receive bakuchiol
• Retinol
This group will receive retinol

Locations

Country	Name	City	State
United States	UC Davis Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 week
Primary	Percentage of Participants With Change in Appearance of Skin Pigmentation	Assessed using image analysis based assessment of facial pigment	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.	Assessed at Week 4, 8, and 12.
Secondary	Number of Reports of Facial Erythema Assessment	Image analysis based assessment of facial erythema	week 4, week 8 and week 12