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

Institute of Skin and Product Evaluation, Italy

Status: Unknown

Conditions: Skin Aging

Treatments: Other: Base cream; Other: Omega7 Sea Buckthorn Oil Cream; Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00767156

E11UE15UE25US14C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups, including a placebo group

SBA24 capsule plus Omega7 cream

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule

Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule

SBA24 capsule plus base cream

Active Comparator group

Description:

the subjects took SBA24 sea buckthorn oil capsule and apply a base cream

Treatment:

Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule

Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule

Omega7 Cream

Active Comparator group

Description:

The subjects Omega 7 Sea Buckthorn Oil Cream, twice per day

Treatment:

Other: Omega7 Sea Buckthorn Oil Cream

Base cream

Placebo Comparator group

Description:

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

Treatment:

Other: Base cream