Clinical trial NCT00767156: Effects of Oral and Topical Sea Buckthorn Oil Treatments on Skin Aging
Official title: Subjective and Instrumental Evaluation of the Effects of Treatments With Two Sea Buckthorn Oil Products on Cutaneous Aging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Aging
Keywords: Sea buckthorn oil, Oral and topical treatment, Skin aging
Lead sponsor: Institute of Skin and Product Evaluation, Italy
Sponsor class: OTHER
Collaborators: name: Aromtech Ltd.
First posted: 2008-10-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Decrease of signs of skin aging
timeFrame: 8 weeks
Secondary outcomes:
measure: Subjects self-assessment of the efficacy of the treatment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ISPE Srl
Study officials:
affiliation: Research Director
name: Adriana Bonfigli, PhD
role: PRINCIPAL_INVESTIGATOR
References: