High Total Antioxidant Capacity Products Added to Diet

Healthy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975728
• Other study ID #: DermIng E0709
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2009
• Last updated: June 22, 2011
• Start date: February 2010
• Est. completion date: October 2010

Study information

• Verified date: June 2011
• Source: Derming SRL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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.

Description:

To determine the antioxidant activity of the tested product the following clinical and instrumental evaluations will be performed:

1. 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.

2. 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:

1. 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.

2. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• pregnancy

• lactation

• smoking >10 cigarettes per day

• drinking more then one glass of wine per day

• drinking super-alcoholics

• assumption of food supplement

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Alixir - Pomegranate, apple and Açai drink / Placebo
250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks

Locations

Country	Name	City	State
Italy	DermIng S.r.l	Monza	MB

Sponsors (2)

Lead Sponsor	Collaborator
Derming SRL	University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythema evaluation (MED-optical densitometry)		T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment), T12 and T16 (follow-up visits - 12 and 16 weeks after T0)	Yes
Secondary	Skin evaluations (Skin texture - Hydration - Plastoelasticity - Epicutaneous pH)		T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis	Yes
Secondary	Determination on blood samples of antioxidants diet components		T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis	Yes

External Links

•   Haematological laboratory center
•   Investigator center
•   Sponsor