Skin AgingSBanti-agingNCT00767156
Effects of Oral and Topical Sea Buckthorn Oil Treatments on Skin Aging
A study testing Omega7 Sea Buckthorn Oil Cream, Base cream and SBA24 Sea Buckthorn Oil Capsule in people with Skin Aging, run by Institute of Skin and Product Evaluation, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Omega7 Sea Buckthorn Oil Cream, Base cream and SBA24 Sea Buckthorn Oil Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
ISPE Srl
Milan, 20125
Adriana Bonfigli, PhD, +39 0267100695/+39 0267100703, a.bonfigli@ispe.it
Adriana Bonfigli, PhD
About this study
Official title: Subjective and Instrumental Evaluation of the Effects of Treatments With Two Sea Buckthorn Oil Products on Cutaneous Aging
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.
Read the 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.
- Conditions
- Skin Aging
- Being tested
- Omega7 Sea Buckthorn Oil Cream, Base cream, SBA24 Sea Buckthorn Oil Capsule
- Keywords
- Sea buckthorn oil, Oral and topical treatment, Skin aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega7 Sea Buckthorn Oil CreamOther
The subjects use Omega7 Sea Buckthorn Oil Cream on the face, twice per day
Base creamOther
The subjects use the base cream on the face, twice per day
SBA24 Sea Buckthorn Oil CapsuleDietary supplement
Also called Omega7/Membrasin Capsule, Omega7 Cream
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 CapsuleDietary supplement
Also called Omega7/Membrasin/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
| Study group | Role | What they receive |
|---|---|---|
| SBA24 capsule plus Omega7 cream | Active comparator | the subjects took SBA24 sea buckthorn oil capsule and apply Omega7 cream Receives: Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule |
| SBA24 capsule plus base cream | Active comparator | the subjects took SBA24 sea buckthorn oil capsule and apply a base cream Receives: Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule |
| Omega7 Cream | Active comparator | The subjects Omega 7 Sea Buckthorn Oil Cream, twice per day Receives: Other: Omega7 Sea Buckthorn Oil Cream |
| Base cream | Placebo comparator | The subjects use base cream on the face, twice per day Receives: Other: Base cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of signs of skin aging
Measured: 8 weeks
Secondary outcomes (1)
Subjects self-assessment of the efficacy of the treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Skin and Product Evaluation, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Aromtech Ltd.
- Investigators
- Adriana Bonfigli, PhD, Principal investigator, Research Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767156
- Sponsor's protocol ID
- E11UE15UE25US14C
- Acronym
- SBanti-aging
- Status last verified
- Oct 2008
- First submitted
- 3 Oct 2008
- Last updated
- 6 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective and Instrumental Evaluation of the Effects of Treatments With Two Sea Buckthorn Oil Products on Cutaneous Aging
- ClinicalTrials.gov ID
- NCT00767156
- Acronym / sponsor ID
- SBanti-aging / E11UE15UE25US14C
- Conditions
- Skin Aging
- Keywords
- Sea buckthorn oil, Oral and topical treatment, Skin aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Skin and Product Evaluation, ItalyUniversity, hospital or other
- Collaborators
- Aromtech Ltd.
- Study start
- Oct 2008
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 6 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SBA24 capsule plus Omega7 cream | Active comparator | Dietary Supplement: SBA24 Sea Buckthorn Oil Capsulethe subjects took SBA24 sea buckthorn oil capsule and apply Omega7 cream |
| SBA24 capsule plus base cream | Active comparator | Dietary Supplement: SBA24 Sea Buckthorn Oil Capsulethe subjects took SBA24 sea buckthorn oil capsule and apply a base cream |
| Omega7 Cream | Active comparator | Other: Omega7 Sea Buckthorn Oil CreamThe subjects Omega 7 Sea Buckthorn Oil Cream, twice per day |
| Base cream | Placebo comparator | Other: Base creamThe subjects use base cream on the face, twice per day |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega7 Sea Buckthorn Oil CreamThe subjects use Omega7 Sea Buckthorn Oil Cream on the face, twice per day | Other | Omega7 Cream |
| Base creamThe subjects use the base cream on the face, twice per day | Other | Base cream |
| SBA24 Sea Buckthorn Oil CapsuleAlso: Omega7/Membrasin Capsule, Omega7 CreamThe 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. | Dietary supplement | SBA24 capsule plus Omega7 cream |
| SBA24 Sea Buckthorn Oil CapsuleAlso: Omega7/Membrasin/SBA24 Sea Buckthorn Oil CapsuleTeh 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 | Dietary supplement | SBA24 capsule plus base cream |
Primary outcome
Decrease of signs of skin aging
Time frame: 8 weeks
1 secondary outcome
Subjects self-assessment of the efficacy of the treatment
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Bonfigli, PhD principal investigator
Research Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega7 Sea Buckthorn Oil Cream, Base cream and SBA24 Sea Buckthorn Oil Capsule in people with Skin Aging, run by Institute of Skin and Product Evaluation, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of signs of skin aging (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2008.