Skin HealthNCT02525224
Nutritional Supplement Efficacy on Cellular Protection and Skin Health in Generally Healthy Adults
A study testing Nutritional Supplement in people with Skin Health, run by Pharmanex at 1 site in United States.
Trial summary
Healthy skin has been equated with a healthy diet leading to the "inside out" approach to skin health. Since the skin is the barrier to the external world, healthy skin should lead to overall better health. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Sep 2015
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals must be between 40-75 years of age with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Individuals must present with moderate signs of aging
- Subject is willing and able to participate in all aspects of the study
- Individuals must sign informed consent, photo release consent and confidentiality agreement
- Subject eats 1 or less servings of fatty fish per week
- Subject has a BMI > 19 and < 30
- Subjects who have been on a stable dose of chronic use medications for at least 3 months prior to study participation
- Subjects who, in the opinion of the investigator, are free of any medical condition(s) that might affect study measures
Who cannot join
- Subject failure to provide informed consent
- Individuals that are being treated for cancer or have a history of facial skin cancer on the test areas
- Individuals with sunburn, moderate to pronounced suntan, even skin tones, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results
- Any disease or condition of the skin that the examining investigator deems inappropriate for participation, including rosacea, eczema, psoriasis, and atopic dermatitis
- Individuals currently taking medications which in the opinion of the investigators may interfere with the study. This would include but not be limited to routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids) immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye drops are permitted), and insulin, antibiotics or other topical drugs at the test sites.
- Individuals with uncontrolled metabolic diseases such as diabetes (Type I and II), hypertension, hyperthyroidism or hypothyroidism, severe chronic asthma, immunological disorders such as HIV positive, AIDS and systemic lupus erythematosus or mastectomy for cancer involving removal of lymph nodes
Show all 19Show fewer
- Subject is taking supplemental oral dietary/nutritional supplements containing more than 800 IU of vitamin D, 200 mg fish oil, 200 mg krill oil, 2 mg total carotenoids (lycopene, lutein, etc.) and/or 5 mg resveratrol within 30 days prior to study product administration
- Difficulty in swallowing capsules
- Women known to be pregnant, nursing or planning to become pregnant
- Individuals participating in other facial clinical studies
- Individuals who have routinely used an alpha-hydroxyl-acid (AHA) or a beta-hydroxyl-acid (BHA) containing product within two weeks or Retin-A®, Retin-A Micro®, Renova®, Differin®, Avita®, Tazorac®, or Soriatane® within one month of the study start or have taken Accutane® within one year of the study start. Individuals who have used Retinol in the last six months
- Individuals with inflammatory acne lesions (i.e., papules, pustules, cysts, nodules) at the test site
- Individuals who have had chemical peels or dermabrasion within the last six months
- Individuals with known allergies to fish oil. Individuals currently using topically applied prescription medications where the medication is applied on or near the test site
- Individuals who have sun tanned (sun or tanning beds) in the nude within the past 1 year
- Excessive alcohol use (>2 drinks per day)
- Subject is a current smoker or quit less than 3 years from screening visit
- History of substance abuse
- Use of anti-aging treatment skin care products within 30 days of study enrollment and throughout study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Consulting Services
High Point, North Carolina, 27262
About this study
Healthy skin has been equated with a healthy diet leading to the "inside out" approach to skin health. Since the skin is the barrier to the external world, healthy skin should lead to overall better health. Conversely, the skin derives its nutrition from the internal body requiring the consumption of nutritional supplements for optimal health. This research attempts to examine skin attributes and improved appearance achieved after consumption of a state-of-the-art dietary supplement.
Read the detailed description
Subjects will present to the research center and complete an informed consent. They will undergo assessment for inclusion/exclusion criteria, skin examination, BMI calculation, and a brief medical history. Subjects that are found to be appropriate for study entry will undergo an investigator and subject facial evaluation. In addition, they will undergo noninvasive measurements of TEWL, corneometry, skin elasticity, dermspectrophotometry, and assessment with a biophotonic scanner. Facial photography will also be performed. A target site on the right or left sun protected buttock will be selected and will receive 1, 2, and 3 MED of solar simulated radiation.
Subjects will return to the research center 24 hours after irradiation for photography and erythema scaledermospectrophotometer measurement of the irradiated sites and biopsy of the 2 - 3 MED sites. The MED biopsy site will be consistent for each subject, but will be chosen based on the amount of achieved erythema. A 2mm punch biopsy will be taken of the irradiated site and another adjacent nonirradiated site for a total of 2 skin biopsies that will be closed with 5-0 nylon sutures. The biopsy from the nonirradiated site will be processed and shipped as instructed by the sponsor to a laboratory for epigenetic analysis. All subjects will be dispensed the supplement in a white bottle with a research center label along with a compliance diary. Subjects will return in 2 weeks just for suture removal.
At week 4, subjects will undergo an investigator and subject facial evaluation. In addition, they will undergo noninvasive measurements of TEWL, corneometry, skin elasticity, dermspectrophotometry, and assessment with a biophotonic scanner. Subjects will be redispensed study supplements.
Subjects will return to the research facility at week 8 and undergo noninvasive measurements of TEWL, corneometry, skin elasticity, dermspectrophotometry, and assessment with a biophotonic scanner. A target site on the right or left sun protected buttock will be selected and will receive 1, 2, and 3 MED of solar simulated radiation. All supplement bottles and unused product will be collected. Subjects will return to the research center 24 hours after irradiation for photography and erythema scale dermospectrophotometer measurement of the irradiated sites and biopsy of the 2-3 MED sites. The biopsy site will be the same MEDs as the original biopsy site at baseline. A 2mm punch biopsy will be taken of the irradiated site and another adjacent nonirradiated site for a total of 2 skin biopsies that will be closed with 5-0 nylon sutures. The biopsy from the nonirradiated site will be processed and shipped as instructed by the sponsor to a laboratory for epigenetic analysis. All supplement bottles and unused product will be collected. All bottles and unused product will be returned to the sponsor.
Subjects will return to the research center at week 10 for suture removal only.
- Conditions
- Skin Health
- Being tested
- Nutritional Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional SupplementDietary supplement
2 Hard-shell liquid capsules taken twice daily with breakfast and dinner.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Supplement | Other | Proprietary nutritional supplement Receives: Dietary Supplement: Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular protection of the skin
The primary efficacy endpoint is to determine the effects of a nutritional supplement on cellular protection of the skin induced by UV radiation in generally healthy adults as determined by a reduction in sunburn cell count following supplement ingestion for 8 weeks.
Measured: 8 weeks
Secondary outcomes (1)
Skin Health
The secondary efficacy endpoint is to assess improvement in skin health characteristics in subjects consuming a dietary supplement as evidenced by improvement in the dermatologist investigator overall visual assessment of lines/wrinkles, firmness/elasticity, radiance, skin texture/smoothness, and overall appearance.
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 posted17 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatology Consulting Services, High Point NC
- Responsible party
- Sponsor
- Investigators
- Zoe D Draelos, MD, Principal investigator, Dermatology Consulting Services, High Point NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525224
- Sponsor's protocol ID
- 15-PHX-0001
- Other IDs
- DCS-50-15
- Status last verified
- Mar 2020
- First submitted
- 13 Aug 2015
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Supplement Efficacy on Cellular Protection and Skin Health in Generally Healthy Adults
- ClinicalTrials.gov ID
- NCT02525224
- Acronym / sponsor ID
- 15-PHX-0001
- Conditions
- Skin Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Collaborators
- Dermatology Consulting Services, High Point NC
- Study start
- Jul 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Aug 2015 (estimated)
- 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.
Healthy skin has been equated with a healthy diet leading to the "inside out" approach to skin health. Since the skin is the barrier to the external world, healthy skin should lead to overall better health. Conversely, the skin derives its nutrition from the internal body requiring the consumption of nutritional supplements for optimal health. This research attempts to examine skin attributes and improved appearance achieved after consumption of a state-of-the-art dietary supplement.
Detailed description
Subjects will present to the research center and complete an informed consent. They will undergo assessment for inclusion/exclusion criteria, skin examination, BMI calculation, and a brief medical history. Subjects that are found to be appropriate for study entry will undergo an investigator and subject facial evaluation. In addition, they will undergo noninvasive measurements of TEWL, corneometry, skin elasticity, dermspectrophotometry, and assessment with a biophotonic scanner. Facial photography will also be performed. A target site on the right or left sun protected buttock will be selected and will receive 1, 2, and 3 MED of solar simulated radiation.
Subjects will return to the research center 24 hours after irradiation for photography and erythema scaledermospectrophotometer measurement of the irradiated sites and biopsy of the 2 - 3 MED sites. The MED biopsy site will be consistent for each subject, but will be chosen based on the amount of achieved erythema. A 2mm punch biopsy will be taken of the irradiated site and another adjacent nonirradiated site for a total of 2 skin biopsies that will be closed with 5-0 nylon sutures. The biopsy from the nonirradiated site will be processed and shipped as instructed by the sponsor to a laboratory for epigenetic analysis. All subjects will be dispensed the supplement in a white bottle with a research center label along with a compliance diary. Subjects will return in 2 weeks just for suture removal.
At week 4, subjects will undergo an investigator and subject facial evaluation. In addition, they will undergo noninvasive measurements of TEWL, corneometry, skin elasticity, dermspectrophotometry, and assessment with a biophotonic scanner. Subjects will be redispensed study supplements.
Subjects will return to the research facility at week 8 and undergo noninvasive measurements of TEWL, corneometry, skin elasticity, dermspectrophotometry, and assessment with a biophotonic scanner. A target site on the right or left sun protected buttock will be selected and will receive 1, 2, and 3 MED of solar simulated radiation. All supplement bottles and unused product will be collected. Subjects will return to the research center 24 hours after irradiation for photography and erythema scale dermospectrophotometer measurement of the irradiated sites and biopsy of the 2-3 MED sites. The biopsy site will be the same MEDs as the original biopsy site at baseline. A 2mm punch biopsy will be taken of the irradiated site and another adjacent nonirradiated site for a total of 2 skin biopsies that will be closed with 5-0 nylon sutures. The biopsy from the nonirradiated site will be processed and shipped as instructed by the sponsor to a laboratory for epigenetic analysis. All supplement bottles and unused product will be collected. All bottles and unused product will be returned to the sponsor.
Subjects will return to the research center at week 10 for suture removal only.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplement | Other | Dietary Supplement: Nutritional SupplementProprietary nutritional supplement |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals must be between 40-75 years of age with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Individuals must present with moderate signs of aging
- Subject is willing and able to participate in all aspects of the study
- Individuals must sign informed consent, photo release consent and confidentiality agreement
- Subject eats 1 or less servings of fatty fish per week
Key exclusion criteria (19 listed)
- Subject failure to provide informed consent
- Individuals that are being treated for cancer or have a history of facial skin cancer on the test areas
- Individuals with sunburn, moderate to pronounced suntan, even skin tones, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results
- Any disease or condition of the skin that the examining investigator deems inappropriate for participation, including rosacea, eczema, psoriasis, and atopic dermatitis
- Individuals currently taking medications which in the opinion of the investigators may interfere with the study. This would include but not be limited to routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids) immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye drops are permitted), and insulin, antibiotics or other topical drugs at the test sites.
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 |
|---|---|---|
| Nutritional Supplement2 Hard-shell liquid capsules taken twice daily with breakfast and dinner. | Dietary supplement | Nutritional Supplement |
Primary outcome
Cellular protection of the skin
Time frame: 8 weeks
The primary efficacy endpoint is to determine the effects of a nutritional supplement on cellular protection of the skin induced by UV radiation in generally healthy adults as determined by a reduction in sunburn cell count following supplement ingestion for 8 weeks.
1 secondary outcome
Skin Health
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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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.
Zoe D Draelos, MD principal investigator
Dermatology Consulting Services, High Point NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Supplement in people with Skin Health, run by Pharmanex at 1 site in United States.
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 8 inclusion and 19 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: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellular protection of the skin (time frame: 8 weeks). 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 4 Mar 2020.