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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Institute of Skin and Product Evaluation, Italy.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Aromtech Ltd.
Information provided by:
Institute of Skin and Product Evaluation, Italy
ClinicalTrials.gov Identifier:
NCT00767156
First received: October 3, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose
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 Intervention
Skin Aging
 Other: Omega7 Sea Buckthorn Oil Cream
Other: Base cream
Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Subjective and Instrumental Evaluation of the Effects of Treatments With Two Sea Buckthorn Oil Products on Cutaneous Aging

Resource links provided by NLM:

MedlinePlus related topics: Skin Aging
U.S. FDA Resources

Further study details as provided by Institute of Skin and Product Evaluation, Italy:

Primary Outcome Measures:
  • Decrease of signs of skin aging [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjects self-assessment of the efficacy of the treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 60
Study Start Date: October 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767156

Locations
Italy
ISPE Srl Not yet recruiting
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     History of Changes
Other Study ID Numbers: E11UE15UE25US14C 
Study First Received: October 3, 2008
Last Updated: October 3, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by Institute of Skin and Product Evaluation, Italy:
Sea buckthorn oil, Oral and topical treatment, Skin aging

ClinicalTrials.gov processed this record on September 23, 2016