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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Institute of Skin and Product Evaluation, Italy.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00767156
First Posted: October 6, 2008
Last Update Posted: October 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aromtech Ltd.
Information provided by:
Institute of Skin and Product Evaluation, Italy
October 3, 2008
October 6, 2008
October 6, 2008
October 2008
November 2008   (Final data collection date for primary outcome measure)
Decrease of signs of skin aging [ Time Frame: 8 weeks ]
Same as current
No Changes Posted
Subjects self-assessment of the efficacy of the treatment [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
 
Effects of Oral and Topical Sea Buckthorn Oil Treatments on Skin Aging
Subjective and Instrumental Evaluation of the Effects of Treatments With Two Sea Buckthorn Oil Products on Cutaneous Aging
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Skin Aging
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
December 2008
November 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
30 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00767156
E11UE15UE25US14C
No
Not Provided
Not Provided
Adriana Bonfigli, ISPE
Institute of Skin and Product Evaluation, Italy
Aromtech Ltd.
Principal Investigator: Adriana Bonfigli, PhD Research Director
Institute of Skin and Product Evaluation, Italy
October 2008

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