Wrinkle Clinical Trial
Official title:
Comparison of the Cosmetic Effects of Bakuchiol and Retinol
Verified date | October 2021 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Subjects will be assigned to a retinoid cream or bakuchiol to compare the cosmetic effects. This will take place over a 12 week period.
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 |
Country | Name | City | State |
---|---|---|---|
United States | UC Davis Department of Dermatology | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
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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