Effects of an Oral Herbal Supplement on Skin Aging, Hydration, and Elasticity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how an oral herbal supplementation influences facial skin elasticity and facial hydration as well as markers of photoaging (erythema and pigmentation).

Detailed Description
-----------------
Skin is the largest organ of the body and skin aging represents a primary indicator of the aging process in the body. Photoaging is among the most crucial factors that cause skin aging damage. Photoaged skin is primarily induced by prolonged exposure to ultraviolet radiation leading to the appearance of increased skin pigmentation, reduced elasticity, and pronounced wrinkles. There has been an increasing recognition of the influence of nutrition on skin health with dietary elements emerging as a viable alternative approach to preventing photoaging. The aim of this study is to understand how oral supplementation impacts photoaged skin, facial hydration, and facial elasticity.

Official Title
-----------------
Prospective, Double-Blinded, Randomized Placebo Controlled Study of an Oral Herbal Supplement on Photoaged Skin and Elasticity

Conditions
-----------------
Photoaging

Intervention / Treatment
-----------------
* Dietary Supplement: Oral herbal supplement
* Dietary Supplement: Oral placebo supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Women who are 35 to 55 years of age Exclusion Criteria: Individuals who are pregnant or breastfeeding. Prisoners. Adults unable to consent. Those who are unwilling to discontinue topical probiotics, topical hydroquinone, retinoids, bakuchiol, vitamin C, or acetyl zingerone containing products for two weeks to meet the washout criteria prior to enrolling. Subjects with any of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during the study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid 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. Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study. Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years. Any known allergy to any of the ingredients in the study product. Those who have been on an oral antibiotic within 1 month prior enrolling Those who are unwilling to discontinue oral probiotics-based supplementation or supplement ingredients found in the study's oral, product 1 month prior to enrollment

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Herbal Supplement<br>Oral supplement containing an herbal blend | Dietary Supplement: Oral herbal supplement<br>* Take one capsule daily<br>|
| Placebo Comparator: Oral Placebo Supplement<br>Oral placebo supplement | Dietary Supplement: Oral placebo supplement<br>* Take one capsule daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skin Elasticity | Skin elasticity measured with a handheld non-invasive device (Cutometer, Delfin Technologies Ltd.) | 8 weeks | 
| Change in Skin Hydration | The skin capacitance will be measured with a handheld non-invasive device (Skin MoistureMeterSC, Delfin Technologies Ltd.). The measurement is in arbitrary units per manufacturer. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skin pigmentation intensity | Facial photographs will be obtained and analyzed utilizing the BTBP 3D Clarity Pro Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA, USA). The measurement will analyze pigment intensity and will be reported as a relative change from baseline. | 8 weeks | 
| Change in appearance of facial wrinkles | Facial photographs will be obtained and analyzed utilizing the BTBP 3D Clarity Pro Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA, USA). The measurement will analyze wrinkle severity that is a measure of both the wrinkle depth and width and will be reported as a relative change from baseline. | 8 weeks | 
| Change in the skin erythema | Facial photographs will be obtained and analyzed utilizing the BTBP 3D Clarity Pro Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA, USA). The measurement will analyze erythema intensity and will be reported as a relative change from baseline. | 8 weeks | 
| Change in skin transepidermal water loss | Skin transepidermal water loss measured with a handheld non-invasive device (Vapometer, Delfin Technologies Ltd.) | 8 weeks | 
| Self-perception of skin (changes in facial fine lines and wrinkles, firmness, etc) | Assessed with the use of a subjective questionnaire to be completed by participants. Self-perception will be measured by rating symptoms of skin improvement, clarity, smoothness, etc.) | 8 weeks | 
| Product Tolerability | Assessed with the use of a tolerability questionnaire to be completed by participants. Tolerability will be measured by rating symptoms such as burning, stinging, and scaling. | 8 weeks |