HealthyPhase 3NCT00975728
High Total Antioxidant Capacity Products Added to Diet
A Phase 3 study of Healthy, run by Derming SRL at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the antioxidant activity on skin photo induced damage of a food supplement and its anti-age properties. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2010to Oct 2010
- Phase
- Phase 3
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult volunteers of both sexes, between 30 and 60 years of age
- Phototype II or III ( Fitzpatrick's classification)
- Volunteers in a good general state of health in the Investigator opinion
- Volunteers not taking drugs or undergoing surgical procedure
- Volunteers who are giving a written informed consent
Who cannot join
- pregnancy
- lactation
- smoking >10 cigarettes per day
- drinking more then one glass of wine per day
- drinking super-alcoholics
- assumption of food supplement
Show all 24Show fewer
- change in the normal habits in the last month
- participation in a similar study during the previous 3 months
- insufficient adhesion to the study protocol
- dermatological disease
- clinical and significant skin condition on the test area (e.g. lesions, scars,malformations)
- diabetes
- endocrine disease
- hepatic, renal or cardiac disorder
- cancer
- topical drugs or surgical procedure on the test areas during the previous 3 months
- systemic corticosteroids
- aspirin or non-steroid anti-inflammatory drugs (FANS)
- diuretic drugs
- antibiotics and chemotherapics
- psychotropic drugs
- retinoids
- psoralens
- cardiologic and vascular drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Total Antioxidant Capacity (TAC) Products Added to Diet: Clinical and Instrumental Evaluation of Their Effect on Skin Surface Parameters and on Photo-induced Acute Damage of the Skin (Double Blind Clinical Study vs Placebo)
The purpose of this study is to evaluate the antioxidant activity on skin photo induced damage of a food supplement and its anti-age properties.
Read the detailed description
To determine the antioxidant activity of the tested product the following clinical and instrumental evaluations will be performed:
- Evaluation of experimentally induced erythema inhibition: in basal conditions, before starting the assumption of the test product/placebo, and at T4, T8, T12, T16 weeks, each volunteer wll be exposed at the level of dorsal skin to six incremental doses of UVR (ultraviolet radiations mJ/cm2 ) in order to determine the MED (minimal erythema dose of unprotected skin). 20+/-4 hours after the UV exposure clinical and instrumental (optical densitometry) evaluations of skin erythema and photographic documentation (only on 16 preselected cases) will be performed.
- Blood samples collection for the determination of the principal antioxidants concentration (for example: lutein, carotene, lycopene and E vitamin): at T0, T4, T8 and T12 blood samples (5 ml of venous blood) will be collected on each volunteer by the Medical Staff. The samples will be sent to an external laboratory for haematologic control task.
To determine the anti-age properties of the tested product the following clinical and instrumental evaluations will be performed:
- Non Invasive, instrumental evaluation of principal skin parameters: epicutaneous pH, skin hydration (skin electrical capacitance), skin firmness (plastoelasticity), skin texture (skin surface irregularity index - FFT on skin replicas) measurements will be performed at T0 and T8 mono-laterally at level of volar forearm medium third, left or right side according to a previously defined randomization list.
- Clinical pictures with UV flash (Wood's light): at T0 and T8, 20 preselected cases of fairy skinned volunteers (selected on the basis of clinical ananmnesis regarding photosensitivity) will be submitted to the realization of clinical pictures at the level of the face using a special UV flash, able to highlight melanin spots, even if not yet visible at the naked eye.
Moreover aim of the study is also to evaluate the best dosage of the beverage (1 or 2 servings of 250 ml/a day).
- Conditions
- Healthy
- Being tested
- Alixir - Pomegranate, apple and Açai drink / Placebo
- Keywords
- Anti-oxidant, Açai, Food supplement, Sun protection, Skin erythema prevention, Anti-oxidant efficacy, Anti-age efficacy, Skin photo-induced damage protection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alixir - Pomegranate, apple and Açai drink / PlaceboDietary supplement
Also called Barilla Alixir (code 824/825), Anti-oxidant drink, Açai drink
250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Product 825 (2-servings day) | Experimental | 30 subjects drinking 2 servings day of Product 825 for 8 weeks Receives: Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo |
| Group 1 Product 824 (2 servings-day) | Experimental | 30 subjects drinking 2 servings-day of Product 824 for 8 weeks Receives: Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo |
| Group 2 Product 825 (1 serving-day) | Experimental | 30 subjects drinking 1 serving-day of Product 825 for 8 weeks Receives: Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo |
| Gruop 2 Product 824 (1 serving-day) | Experimental | 30 subjects drinking 1 serving-day of Product 824 for 8 weeks Receives: Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema evaluation (MED-optical densitometry)
Measured: T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment), T12 and T16 (follow-up visits - 12 and 16 weeks after T0)
Secondary outcomes (2)
Skin evaluations (Skin texture - Hydration - Plastoelasticity - Epicutaneous pH)
Measured: T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis
Determination on blood samples of antioxidants diet components
Measured: T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derming SRL
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna
- Investigators
- Adele Sparavigna, Doctor, Principal investigator, Derming SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975728
- Sponsor's protocol ID
- DermIng E0709
- Status last verified
- Jun 2011
- First submitted
- 10 Sep 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Elsner P., Berardesca E., Maibach H. Bioengineering of the skin: Water and the stratum corneum CRC Press, Boca Raton, 1994; Fuga GC, Spina C, Cavallotti C, Di Palma A, Lombardi G, Marmo W Computerized reflected optical densitometry. A research on the colour of the skin - Journal of Applied Cosmetology, 8:91-110,1990; Cosmetic, Toiletry and Fragrance Association of South Africa (CFTA), The European Cosmetic Toiletry and Perfumery Association (COLIPA), Japan Cosmetic Industry Association (JCIA) International sun protection factor (SPF) test method; October 2002; ICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: May 1996; Setaro M., Sparavigna A. Morphological Evaluation of Skin Surface by Fourier's Transform: A Study on the Phase and the Modulus
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Total Antioxidant Capacity (TAC) Products Added to Diet: Clinical and Instrumental Evaluation of Their Effect on Skin Surface Parameters and on Photo-induced Acute Damage of the Skin (Double Blind Clinical Study vs Placebo)
- ClinicalTrials.gov ID
- NCT00975728
- Acronym / sponsor ID
- DermIng E0709
- Conditions
- Healthy
- Keywords
- Anti-oxidant, Açai, Food supplement, Sun protection, Skin erythema prevention, Anti-oxidant efficacy, Anti-age efficacy, Skin photo-induced damage protection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Collaborators
- University of Bologna
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Sep 2009 (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.
The purpose of this study is to evaluate the antioxidant activity on skin photo induced damage of a food supplement and its anti-age properties.
Detailed description
To determine the antioxidant activity of the tested product the following clinical and instrumental evaluations will be performed:
- Evaluation of experimentally induced erythema inhibition: in basal conditions, before starting the assumption of the test product/placebo, and at T4, T8, T12, T16 weeks, each volunteer wll be exposed at the level of dorsal skin to six incremental doses of UVR (ultraviolet radiations mJ/cm2 ) in order to determine the MED (minimal erythema dose of unprotected skin). 20+/-4 hours after the UV exposure clinical and instrumental (optical densitometry) evaluations of skin erythema and photographic documentation (only on 16 preselected cases) will be performed.
- Blood samples collection for the determination of the principal antioxidants concentration (for example: lutein, carotene, lycopene and E vitamin): at T0, T4, T8 and T12 blood samples (5 ml of venous blood) will be collected on each volunteer by the Medical Staff. The samples will be sent to an external laboratory for haematologic control task.
To determine the anti-age properties of the tested product the following clinical and instrumental evaluations will be performed:
- Non Invasive, instrumental evaluation of principal skin parameters: epicutaneous pH, skin hydration (skin electrical capacitance), skin firmness (plastoelasticity), skin texture (skin surface irregularity index - FFT on skin replicas) measurements will be performed at T0 and T8 mono-laterally at level of volar forearm medium third, left or right side according to a previously defined randomization list.
- Clinical pictures with UV flash (Wood's light): at T0 and T8, 20 preselected cases of fairy skinned volunteers (selected on the basis of clinical ananmnesis regarding photosensitivity) will be submitted to the realization of clinical pictures at the level of the face using a special UV flash, able to highlight melanin spots, even if not yet visible at the naked eye.
Moreover aim of the study is also to evaluate the best dosage of the beverage (1 or 2 servings of 250 ml/a day).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 Product 825 (2-servings day) | Experimental | Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo30 subjects drinking 2 servings day of Product 825 for 8 weeks |
| Group 1 Product 824 (2 servings-day) | Experimental | Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo30 subjects drinking 2 servings-day of Product 824 for 8 weeks |
| Group 2 Product 825 (1 serving-day) | Experimental | Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo30 subjects drinking 1 serving-day of Product 825 for 8 weeks |
| Gruop 2 Product 824 (1 serving-day) | Experimental | Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo30 subjects drinking 1 serving-day of Product 824 for 8 weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult volunteers of both sexes, between 30 and 60 years of age
- Phototype II or III ( Fitzpatrick's classification)
- Volunteers in a good general state of health in the Investigator opinion
- Volunteers not taking drugs or undergoing surgical procedure
- Volunteers who are giving a written informed consent
Key exclusion criteria (24 listed)
- pregnancy
- lactation
- smoking >10 cigarettes per day
- drinking more then one glass of wine per day
- drinking super-alcoholics
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 |
|---|---|---|
| Alixir - Pomegranate, apple and Açai drink / PlaceboAlso: Barilla Alixir (code 824/825), Anti-oxidant drink, Açai drink250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks | Dietary supplement | Group 1 Product 824 (2 servings-day), Group 1 Product 825 (2-servings day), Group 2 Product 825 (1 serving-day), Gruop 2 Product 824 (1 serving-day) |
Primary outcome
Erythema evaluation (MED-optical densitometry)
Time frame: T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment), T12 and T16 (follow-up visits - 12 and 16 weeks after T0)
2 secondary outcomes
Skin evaluations (Skin texture - Hydration - Plastoelasticity - Epicutaneous pH)
Time frame: T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis
Determination on blood samples of antioxidants diet components
Time frame: T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis
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 23 Jun 2011.
- BackgroundElsner P., Berardesca E., Maibach H. Bioengineering of the skin: Water and the stratum corneum CRC Press, Boca Raton, 1994; Fuga GC, Spina C, Cavallotti C, Di Palma A, Lombardi G, Marmo W Computerized reflected optical densitometry. A research on the colour of the skin - Journal of Applied Cosmetology, 8:91-110,1990; Cosmetic, Toiletry and Fragrance Association of South Africa (CFTA), The European Cosmetic Toiletry and Perfumery Association (COLIPA), Japan Cosmetic Industry Association (JCIA) International sun protection factor (SPF) test method; October 2002; ICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: May 1996; Setaro M., Sparavigna A. Morphological Evaluation of Skin Surface by Fourier's Transform: A Study on the Phase and the Modulus
- Investigator centerLink provided by the sponsor.
- Haematological laboratory centerLink provided by the sponsor.
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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.
Adele Sparavigna, Doctor principal investigator
Derming SRL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Healthy, run by Derming SRL at 1 site in Italy.
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 5 inclusion and 24 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 23 Jun 2011. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Erythema evaluation (MED-optical densitometry) (time frame: T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment), T12 and T16 (follow-up visits - 12 and 16 weeks after T0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00975728, which also lists 1 linked publication.
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 23 Jun 2011.