Effects of Oral and Topical Sea Buckthorn Oil Treatments on Skin Aging
NCT ID: NCT00767156
Last Updated: 2008-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2008-10-31
2008-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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SBA24 capsule plus Omega7 cream
the subjects took SBA24 sea buckthorn oil capsule and apply Omega7 cream
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.
SBA24 capsule plus base cream
the subjects took SBA24 sea buckthorn oil capsule and apply a base cream
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
Omega7 Cream
The subjects Omega 7 Sea Buckthorn Oil Cream, twice per day
Omega7 Sea Buckthorn Oil Cream
The subjects use Omega7 Sea Buckthorn Oil Cream on the face, twice per day
Base cream
The subjects use base cream on the face, twice per day
Base cream
The subjects use the base cream on the face, twice per day
Interventions
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Omega7 Sea Buckthorn Oil Cream
The subjects use Omega7 Sea Buckthorn Oil Cream on the face, twice per day
Base cream
The subjects use the base cream on the face, twice per day
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
60 Years
FEMALE
Yes
Sponsors
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Aromtech Ltd.
INDUSTRY
Institute of Skin and Product Evaluation, Italy
OTHER
Responsible Party
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ISPE
Principal Investigators
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Adriana Bonfigli, PhD
Role: PRINCIPAL_INVESTIGATOR
Research Director
Locations
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ISPE Srl
Milan, , Italy
Countries
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Facility Contacts
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Adriana Bonfigli, PhD
Role: primary
Other Identifiers
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E11UE15UE25US14C
Identifier Type: -
Identifier Source: org_study_id