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Sponsors and Collaborators: |
Institute of Skin and Product Evaluation, Italy Aromtech Ltd. |
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Information provided by: | Institute of Skin and Product Evaluation, Italy |
ClinicalTrials.gov Identifier: | NCT00767156 |
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.
Condition | Intervention |
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Skin Aging |
Other: Omega7 Sea Buckthorn Oil Cream Other: Base cream Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Subjective and Instrumental Evaluation of the Effects of Treatments With Two Sea Buckthorn Oil Products on Cutaneous Aging |
Estimated Enrollment: | 60 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SBA24 capsule plus Omega7 cream: Active Comparator
the subjects took SBA24 sea buckthorn oil capsule and apply Omega7 cream
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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.
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SBA24 capsule plus base cream: Active Comparator
the subjects took SBA24 sea buckthorn oil capsule and apply a base cream
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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
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Omega7 Cream: Active Comparator
The subjects Omega 7 Sea Buckthorn Oil Cream, twice per day
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Other: Omega7 Sea Buckthorn Oil Cream
The subjects use Omega7 Sea Buckthorn Oil Cream on the face, twice per day
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Base cream: Placebo Comparator
The subjects use base cream on the face, twice per day
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Other: Base cream
The subjects use the base cream on the face, twice per day
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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:
Ages Eligible for Study: | 30 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | ISPE ( Adriana Bonfigli ) |
Study ID Numbers: | E11UE15UE25US14C |
Study First Received: | October 3, 2008 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00767156 |
Health Authority: | Italy: Ethics Committee |
Sea buckthorn oil, Oral and topical treatment, Skin aging |