Status:

UNKNOWN

Effects of Oral and Topical Sea Buckthorn Oil Treatments on Skin Aging

Lead Sponsor:

Institute of Skin and Product Evaluation, Italy

Collaborating Sponsors:

Aromtech Ltd.

Conditions:

Skin Aging

Eligibility:

FEMALE

30-60 years

Phase:

NA

Brief Summary

The effect of oral supplementation of SBA24 sea buckthorn oil capsule and topical application of Omega7 sea buckthorn cream on skin ageing is studied in a single blind, parallel study.

Detailed Description

The study is carried out on two groups of female volunteers, 30 in each group, of age 30 to 60 years, in compliance with the principles established by the World Medical Association in the Declaration ...

Eligibility Criteria

Inclusion

  • Female subjects 30 - 60 years old with Fitzpatrick skin type I-IV \& in good general health, with facial skin manifestation related to photoaging (wrinkles, dyschromias, tissue looseness etc.)
  • Subjects must have discontinued the use of topical retinoid products for 6 months prior to study entry and of systemic retinoids for 1 year prior to study entry.
  • Subjects must have discontinued the use of topical alpha-hydroxy, \&/or beta-hydroxy products for 45 days prior to study entry \& all other topical facial medication to the skin immediately prior to study entry.
  • Subjects must have discontinued the use of systemic antiaging or antioxidant products for at least 2 months prior to study entry.
  • Subjects must be willing \& able to follow all study directions \& to commit to all follow-up visits for the duration of the study.
  • Subjects must have completed the informed consent process.
  • Subjects must be willing to avoid direct daily sun exposure on the face or the use of tanning beds.

Exclusion

  • Pregnant or nursing females.
  • Subjects with a history of unusual skin reactions to skin care toiletry products, cosmetics, or sensitivity to any of the test article components.
  • Previous facial treatments with any dermal fillers (i.e. collagen, hyaluronic acid etc)
  • Concurrent therapy, systemic diseases, or skin disorders (such as eczema, psoriasis, severe acne etc.) which may interfere with the evaluation of the test articles or increase risk to the subject.
  • Subjects currently involved in another clinical investigation or who have been involved within a period of 30 days prior to admission in this study.

Key Trial Info

Start Date :

October 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2008

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00767156

Start Date

October 1 2008

End Date

December 1 2008

Last Update

October 6 2008

Active Locations (1)

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1

ISPE Srl

Milan, Italy, 20125