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

NCT ID: NCT00767156

Last Updated: 2008-10-06

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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:

* 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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Skin Aging

Keywords

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Sea buckthorn oil, Oral and topical treatment, Skin aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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SBA24 capsule plus Omega7 cream

the subjects took SBA24 sea buckthorn oil capsule and apply Omega7 cream

Group Type ACTIVE_COMPARATOR

SBA24 Sea Buckthorn Oil Capsule

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

SBA24 Sea Buckthorn Oil Capsule

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

Omega7 Sea Buckthorn Oil Cream

Intervention Type OTHER

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

Group Type PLACEBO_COMPARATOR

Base cream

Intervention Type OTHER

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

Intervention Type OTHER

Base cream

The subjects use the base cream on the face, twice per day

Intervention Type OTHER

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.

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Omega7/Membrasin Capsule, Omega7 Cream Omega7/Membrasin/SBA24 Sea Buckthorn Oil Capsule

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aromtech Ltd.

INDUSTRY

Sponsor Role collaborator

Institute of Skin and Product Evaluation, Italy

OTHER

Sponsor Role lead

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

Site Status

Countries

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Italy

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