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

Photoaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06146140
• Other study ID #: i23-09-Vidya_Skin_Supp
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Integrative Skin Science and Research
• Contact: Laila Afzal
• Phone: 916-524-1216
• Email: laila[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Photoaging

Intervention

Dietary Supplement:
• Oral herbal supplement
Take one capsule daily
• Oral placebo supplement
Take one capsule daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Vidya Herbs

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Skin Elasticity	Skin elasticity measured with a handheld non-invasive device (Cutometer, Delfin Technologies Ltd.)	8 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in skin transepidermal water loss	Skin transepidermal water loss measured with a handheld non-invasive device (Vapometer, Delfin Technologies Ltd.)	8 weeks
Secondary	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
Secondary	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