Comparison of the Cosmetic Effects of Bakuchiol and Retinol

NCT03112863 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 1015536
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wrinkle; Photoaging

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Number of Reports of Stinging, Burning, Itching

  Assessed at Week 4, 8, and 12.

• Number of Reports of Facial Erythema Assessment

  week 4, week 8 and week 12

Study Arms (2)

Bakuchiol

EXPERIMENTAL

Bakuchiol 0.5% applied to face twice daily

Drug: Bakuchiol

Retinol

ACTIVE COMPARATOR

0.5% retinol applied to face nightly

Drug: Retinol

Interventions

Bakuchiol DRUG

This group will receive bakuchiol

Also known as: Bakuchiol 0.5%

Bakuchiol

Retinol DRUG

This group will receive retinol

Also known as: Retinol %

Retinol

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged 30-55

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

MeSH Terms

Interventions

bakuchiol; Vitamin A

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Iryna Rybak
• Organization: UC Davis Dermatology

irybak@ucdavis.edu

916-551-2636

Study Officials

• Raja Sivamani, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind randomized study comparing the effect of bakuchiol and retinoid

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 13, 2017
• Study Start: March 24, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-10

Locations

US (1)