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

Skin Aging Clinical Trial

— SBanti-aging  

Official title:

Subjective and Instrumental Evaluation of the Effects of Treatments With Two Sea Buckthorn Oil Products on Cutaneous Aging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00767156
• Other study ID #: E11UE15UE25US14C
• Status: Not yet recruiting
• Phase: N/A
• First received: October 3, 2008
• Last updated: October 3, 2008
• Start date: October 2008
• Est. completion date: December 2008

Study information

• Verified date: October 2008
• Source: Institute of Skin and Product Evaluation, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Skin Aging

Intervention

Other:
• 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

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.
• 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

Locations

Country	Name	City	State
Italy	ISPE Srl	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Skin and Product Evaluation, Italy	Aromtech Ltd.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of signs of skin aging		8 weeks	No
Secondary	Subjects self-assessment of the efficacy of the treatment		8 weeks	Yes