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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03112863
Other study ID # 1015536
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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