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

• ClinicalTrials.gov Identifier: NCT00767156
• Recruitment Status: Unknown
• First Posted: October 6, 2008
• Last Update Posted: October 6, 2008
• Sponsor: Institute of Skin and Product Evaluation, Italy
• Collaborator: Aromtech Ltd.
• Information provided by: Institute of Skin and Product Evaluation, Italy

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Skin Aging	Other: Omega7 Sea Buckthorn Oil Cream; Other: Base cream; Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Subjective and Instrumental Evaluation of the Effects of Treatments With Two Sea Buckthorn Oil Products on Cutaneous Aging
• Study Start Date: October 2008
• Estimated Primary Completion Date: November 2008
• Estimated Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: SBA24 capsule plus Omega7 cream; the subjects took SBA24 sea buckthorn oil capsule and apply Omega7 cream	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
Active Comparator: SBA24 capsule plus base cream; the subjects took SBA24 sea buckthorn oil capsule and apply a base 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: Omega7 Cream; The subjects Omega 7 Sea Buckthorn Oil Cream, twice per day	Other: Omega7 Sea Buckthorn Oil Cream; The subjects use Omega7 Sea Buckthorn Oil Cream on the face, twice per day
Placebo Comparator: Base cream; The subjects use base cream on the face, twice per day	Other: Base cream; The subjects use the base cream on the face, twice per day

Outcome Measures

Primary Outcome Measures :

1. Decrease of signs of skin aging [ Time Frame: 8 weeks ]

Secondary Outcome Measures :

1. Subjects self-assessment of the efficacy of the treatment [ Time Frame: 8 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Italy

ISPE Srl

Milan, Italy, 20125

Contact: Adriana Bonfigli, PhD +39 0267100695/+39 0267100703 a.bonfigli@ispe.it

Principal Investigator: Adriana Bonfigli, PhD

Sponsors and Collaborators

Institute of Skin and Product Evaluation, Italy

Aromtech Ltd.

Investigators

• Principal Investigator: Adriana Bonfigli, PhD; Research Director

More Information

• Responsible Party: Adriana Bonfigli, ISPE
• ClinicalTrials.gov Identifier: NCT00767156
• Other Study ID Numbers: E11UE15UE25US14C
• First Posted: October 6, 2008
• Last Update Posted: October 6, 2008
• Last Verified: October 2008

Keywords provided by Institute of Skin and Product Evaluation, Italy:

Sea buckthorn oil, Oral and topical treatment, Skin aging