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Effects of Oral and Topical Sea Buckthorn Oil Treatments on Skin Aging (SBanti-aging)

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ClinicalTrials.gov Identifier: NCT00767156
Recruitment Status : Unknown
Verified October 2008 by Institute of Skin and Product Evaluation, Italy.
Recruitment status was:  Not yet recruiting
First Posted : October 6, 2008
Last Update Posted : October 6, 2008
Sponsor:
Collaborator:
Aromtech Ltd.
Information provided by:
Institute of Skin and Product Evaluation, Italy

Tracking Information
First Submitted Date  ICMJE October 3, 2008
First Posted Date  ICMJE October 6, 2008
Last Update Posted Date October 6, 2008
Study Start Date  ICMJE October 2008
Estimated Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2008)
Decrease of signs of skin aging [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2008)
Subjects self-assessment of the efficacy of the treatment [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Oral and Topical Sea Buckthorn Oil Treatments on Skin Aging
Official Title  ICMJE Subjective and Instrumental Evaluation of the Effects of Treatments With Two Sea Buckthorn Oil Products on Cutaneous Aging
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Skin Aging
Intervention  ICMJE
  • 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.
    Other Name: Omega7/Membrasin Capsule, Omega7 Cream
  • 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
    Other Name: Omega7/Membrasin/SBA24 Sea Buckthorn Oil Capsule
Study Arms  ICMJE
  • Active Comparator: SBA24 capsule plus Omega7 cream
    the subjects took SBA24 sea buckthorn oil capsule and apply Omega7 cream
    Intervention: Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule
  • Active Comparator: SBA24 capsule plus base cream
    the subjects took SBA24 sea buckthorn oil capsule and apply a base cream
    Intervention: Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule
  • Active Comparator: Omega7 Cream
    The subjects Omega 7 Sea Buckthorn Oil Cream, twice per day
    Intervention: Other: Omega7 Sea Buckthorn Oil Cream
  • Placebo Comparator: Base cream
    The subjects use base cream on the face, twice per day
    Intervention: Other: Base cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 3, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2008
Estimated Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00767156
Other Study ID Numbers  ICMJE E11UE15UE25US14C
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adriana Bonfigli, ISPE
Study Sponsor  ICMJE Institute of Skin and Product Evaluation, Italy
Collaborators  ICMJE Aromtech Ltd.
Investigators  ICMJE
Principal Investigator: Adriana Bonfigli, PhD Research Director
PRS Account Institute of Skin and Product Evaluation, Italy
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP