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OpenTrials
Completed

NCT Number: NCT03112863

Comparison of the Cosmetic Effects of Bakuchiol and Retinol

Subjects will be assigned to a retinoid cream or bakuchiol to compare the cosmetic effects. This will take place over a 12 week period.

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Key information

Conditions

Wrinkle Photoaging

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bakuchiol

Drug

This group will receive bakuchiol

Other names: Bakuchiol 0.5%

Retinol

Drug

This group will receive retinol

Other names: Retinol %

Primary outcomes

  1. 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.

  2. Percentage of Participants With Change in Appearance of Skin Pigmentation

    Time frame: 12 week

    Assessed using image analysis based assessment of facial pigment

Secondary outcomes

  1. Number of Reports of Stinging, Burning, Itching

    Time frame: 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.

  2. Number of Reports of Facial Erythema Assessment

    Time frame: week 4, week 8 and week 12

    Image analysis based assessment of facial erythema

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2017
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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