PhotoagingNCT06146140
Effects of an Oral Herbal Supplement on Skin Aging, Hydration, and Elasticity
A study testing Oral herbal supplement in people with Photoaging, run by Integrative Skin Science and Research.
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). Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- What is being tested?
- Oral herbal supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who are 35 to 55 years of age
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Double-Blinded, Randomized Placebo Controlled Study of an Oral Herbal Supplement on Photoaged Skin and Elasticity
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).
Read the 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.
- Conditions
- Photoaging
- Being tested
- Oral herbal supplement, Oral placebo supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral herbal supplementDietary supplement
Take one capsule daily
Oral placebo supplementDietary supplement
Take one capsule daily
| Study group | Role | What they receive |
|---|---|---|
| Oral Herbal Supplement | Experimental | Oral supplement containing an herbal blend Receives: Dietary Supplement: Oral herbal supplement |
| Oral Placebo Supplement | Placebo comparator | Oral placebo supplement Receives: Dietary Supplement: Oral placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skin Elasticity
Skin elasticity measured with a handheld non-invasive device (Cutometer, Delfin Technologies Ltd.)
Measured: 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.
Measured: 8 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Change in skin transepidermal water loss
Skin transepidermal water loss measured with a handheld non-invasive device (Vapometer, Delfin Technologies Ltd.)
Measured: 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.)
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vidya Herbs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146140
- Sponsor's protocol ID
- i23-09-Vidya_Skin_Supp
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-Blinded, Randomized Placebo Controlled Study of an Oral Herbal Supplement on Photoaged Skin and Elasticity
- ClinicalTrials.gov ID
- NCT06146140
- Acronym / sponsor ID
- i23-09-Vidya_Skin_Supp
- Conditions
- Photoaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Vidya Herbs
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Herbal Supplement | Experimental | Dietary Supplement: Oral herbal supplementOral supplement containing an herbal blend |
| Oral Placebo Supplement | Placebo comparator | Dietary Supplement: Oral placebo supplementOral placebo supplement |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who are 35 to 55 years of age
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral herbal supplementTake one capsule daily | Dietary supplement | Oral Herbal Supplement |
| Oral placebo supplementTake one capsule daily | Dietary supplement | Oral Placebo Supplement |
Primary outcome
Change in Skin Elasticity
Time frame: 8 weeks
Skin elasticity measured with a handheld non-invasive device (Cutometer, Delfin Technologies Ltd.)
Change in Skin Hydration
Time frame: 8 weeks
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.
6 secondary outcomes
Change in skin pigmentation intensity
Time frame: 8 weeks
Change in appearance of facial wrinkles
Time frame: 8 weeks
Change in the skin erythema
Time frame: 8 weeks
Change in skin transepidermal water loss
Time frame: 8 weeks
Self-perception of skin (changes in facial fine lines and wrinkles, firmness, etc)
Time frame: 8 weeks
Product Tolerability
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Oral herbal supplement in people with Photoaging, run by Integrative Skin Science and Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laila Afzal (916-524-1216, laila@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Elasticity (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.