NCT00975728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_3 healthy

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

5 months

First QC Date

September 10, 2009

Last Update Submit

June 22, 2011

Conditions

Healthy

Keywords

Anti-oxidantAçaiFood supplementSun protectionSkin erythema preventionAnti-oxidant efficacyAnti-age efficacySkin photo-induced damage protection

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • Skin evaluations (Skin texture - Hydration - Plastoelasticity - Epicutaneous pH)

    T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis

  • Determination on blood samples of antioxidants diet components

    T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis

Study Arms (4)

Group 1 Product 825 (2-servings day)

EXPERIMENTAL

30 subjects drinking 2 servings day of Product 825 for 8 weeks

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

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

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

Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo

Interventions

Alixir - Pomegranate, apple and Açai drink / PlaceboDIETARY_SUPPLEMENT

250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks

Also known as: Barilla Alixir (code 824/825), Anti-oxidant drink, Açai drink
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)

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DermIng S.r.l

Monza, MB, 20052, Italy

Location

Related 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

    BACKGROUND

Related Links

Study Officials

  • Adele Sparavigna, Doctor

    Derming SRL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

February 1, 2010

Primary Completion

July 1, 2010

Study Completion

October 1, 2010

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

IT(1)