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

Overview

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.

Full Title of Study: “Subjective and Instrumental Evaluation of the Effects of Treatments With Two Sea Buckthorn Oil Products on Cutaneous Aging”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 2008

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 of Helsinki. In group I, the subjects took SBA24 sea buckthorn oil capsule (2 x 2 capsules per day) and apply two different creams on the face, one cream on each half of the face, twice per day. In group II, the subjects apply only the two creams, one cream on each half of the face, twice per day, for 8 weeks. The assessment is performed on the skin surface of the periocular areas. The efficacy of the active products is assessed on the skin face at the beginning, after 4 weeks and after 8 weeks of treatment using the following instrumental measurements: – cutaneous elasticity (CUTOMETER SEM 575 Courage & Khazaka); – cutaneous hydration level (CORNEOMETER CM 825 Combi 3 Courage & Khazaka); – cutaneous roughness by cutaneous replicas and image analysis (Quantilines, Monaderm); Determination of benefit is based on instrumental measurements and subject self-assessment questionnaires.

Interventions

  • Other: Omega7 Sea Buckthorn Oil Cream
    • The subjects use Omega7 Sea Buckthorn Oil Cream on the face, twice per day
  • Other: Base cream
    • The subjects use the base cream on the face, twice per day
  • Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule
    • The subjects take SBA24 sea Buckthorn Oil Capsules, 2 x 2 capsules (2.0 g oil) per day and use topically Omega7 Sea Buckthorn Oil Cream, twice per day.
  • Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule
    • Teh subjects took SBA24 Sea Buckthorn Oil Capsule, 2 x 2 capsules (2 g oil) per day and use topically the base cream, twice per day

Arms, Groups and Cohorts

  • Active Comparator: SBA24 capsule plus Omega7 cream
    • the subjects took SBA24 sea buckthorn oil capsule and apply Omega7 cream
  • Active Comparator: SBA24 capsule plus base cream
    • the subjects took SBA24 sea buckthorn oil capsule and apply a base cream
  • Active Comparator: Omega7 Cream
    • The subjects Omega 7 Sea Buckthorn Oil Cream, twice per day
  • Placebo Comparator: Base cream
    • The subjects use base cream on the face, twice per day

Clinical Trial Outcome Measures

Primary Measures

  • Decrease of signs of skin aging
    • Time Frame: 8 weeks

Secondary Measures

  • Subjects self-assessment of the efficacy of the treatment
    • Time Frame: 8 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Criteria:

  • 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.

Gender Eligibility: Female

Minimum Age: 30 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Institute of Skin and Product Evaluation, Italy
  • Collaborator
    • Aromtech Ltd.
  • Provider of Information About this Clinical Study
    • Adriana Bonfigli, ISPE
  • Overall Official(s)
    • Adriana Bonfigli, PhD, Principal Investigator, Research Director

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.