Clinical trial NCT06146140: Effects of an Oral Herbal Supplement on Skin Aging, Hydration, and Elasticity
Official title: Prospective, Double-Blinded, Randomized Placebo Controlled Study of an Oral Herbal Supplement on Photoaged Skin and Elasticity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Photoaging
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Vidya Herbs
First posted: 2023-11-24
Enrollment: 36
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Skin Elasticity
timeFrame: 8 weeks
measure: Change in Skin Hydration
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in skin pigmentation intensity
timeFrame: 8 weeks
measure: Change in appearance of facial wrinkles
timeFrame: 8 weeks
measure: Change in the skin erythema
timeFrame: 8 weeks
measure: Change in skin transepidermal water loss
timeFrame: 8 weeks
measure: Self-perception of skin (changes in facial fine lines and wrinkles, firmness, etc)
timeFrame: 8 weeks
measure: Product Tolerability
timeFrame: 8 weeks
Other outcomes:
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