The Effects of a 3-Part Skin Care Regimen on Facial Wrinkles and Biophysical Attributes

Study Overview
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Brief Summary
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The purpose of this study is to analyze various cosmetic endpoints, subjective assessments, and skin parameters such as hydration, transepidermal water loss, fine lines, and wrinkles with the use of a 3-part skin care regimen.

Official Title
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The Effects of a 3-Part Skin Care Regimen on Facial Wrinkles and Biophysical Attributes

Conditions
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Wrinkle

Intervention / Treatment
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* Other: Cleansing Balm
* Other: Facial Serum
* Other: Moisturizer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women between the ages of 35 years old and 65 years old. Must have facial fine lines and wrinkles. Exclusion Criteria: Individuals who are pregnant or breastfeeding. Prisoners Adults unable to consent Individuals who have changed any of their hormonal based contraception within 1 months prior to joining the study. Subjects using any topical retinoid, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment. Subjects with any cosmetic treatments in the past 6 months and who are unwilling to withhold facial cosmetic treatments during the study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, tightening treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin. Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 Step Skin Care Regimen<br>3 different skin care products will be applied to the face | Other: Cleansing Balm<br>* DermResults Cleansing Balm w/ Avocado Oil twice daily<br>Other: Facial Serum<br>* DermResults Advanced Serum w/ Hyaluronic Acid twice daily<br>Other: Moisturizer<br>* DermResults Advanced Moisturizer w/ Hyaluronic Acid twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of facial wrinkles | Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin hydration | Change in skin hydration by SkinMoistureMeterSC measurement | 1 week | 
| Skin hydration | Change in skin hydration by SkinMoistureMeterSC measurement | 4 weeks | 
| Skin hydration | Change in skin hydration by SkinMoistureMeterSC measurement | 8 weeks | 
| Transepidermal water loss | Change in transepidermal water loss measurement by Vapometer | 1 week | 
| Transepidermal water loss | Change in transepidermal water loss measurement by Vapometer | 4 weeks | 
| Transepidermal water loss | Change in transepidermal water loss measurement by Vapometer | 8 weeks | 
| Skin volume | Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System) | 1 week | 
| Skin volume | Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System) | 4 weeks | 
| Skin volume | Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System) | 8 weeks | 
| Skin texture/roughness | Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System | 1 week | 
| Skin texture/roughness | Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System | 4 weeks | 
| Skin texture/roughness | Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System | 8 weeks | 
| Self-perception of skin parameters | Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness | 1 week | 
| Self-perception of skin parameters | Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness | 4 weeks | 
| Self-perception of skin parameters | Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness | 8 weeks | 
| Tolerability of products | Questionnaire based self-assessment about the tolerability of the topical skin products | 1 week | 
| Tolerability of products | Questionnaire based self-assessment about the tolerability of the topical skin products | 4 weeks | 
| Tolerability of products | Questionnaire based self-assessment about the tolerability of the topical skin products | 8 weeks | 
| Appearance of facial wrinkles | Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System) | 4 weeks |