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Comparison of the Cosmetic Effects of Bakuchiol and Retinol

NCT ID: NCT03112863

Last Updated: 2021-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-24

Study Completion Date

2019-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Wrinkle Photoaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind randomized study comparing the effect of bakuchiol and retinoid
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bakuchiol

Bakuchiol 0.5% applied to face twice daily

Group Type EXPERIMENTAL

Bakuchiol

Intervention Type DRUG

This group will receive bakuchiol

Retinol

0.5% retinol applied to face nightly

Group Type ACTIVE_COMPARATOR

Retinol

Intervention Type DRUG

This group will receive retinol

Interventions

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Bakuchiol

This group will receive bakuchiol

Intervention Type DRUG

Retinol

This group will receive retinol

Intervention Type DRUG

Other Intervention Names

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Bakuchiol 0.5% Retinol %

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raja Sivamani, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Locations

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UC Davis Department of Dermatology

Sacramento, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1015536

Identifier Type: -

Identifier Source: org_study_id