Status:

COMPLETED

High Total Antioxidant Capacity Products Added to Diet

Lead Sponsor:

Derming SRL

Collaborating Sponsors:

University of Bologna

Conditions:

Healthy

Eligibility:

All Genders

30-60 years

Phase:

PHASE3

Brief 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.

Detailed 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 basa...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2010

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00975728

Start Date

February 1 2010

End Date

October 1 2010

Last Update

June 23 2011

Active Locations (1)

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1

DermIng S.r.l

Monza, MB, Italy, 20052

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