ClinicalTrials.gg
Status unknownNCT00767156SBanti-agingUpdated Oct 6, 2008

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

An interventional study of Omega7 Sea Buckthorn Oil Cream and Base cream in Skin Aging, sponsored by Institute of Skin and Product Evaluation, Italy. Status unknown at 1 site in Italy. Open to female participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-10-06.

Sponsored by Institute of Skin and Product Evaluation, Italy · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Oct 2008), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
Female
01

Study 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 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.
02

Conditions studied

  • Skin Aging

Keywords

  • Sea buckthorn oil, Oral and topical treatment, Skin aging
03

In context

Lead sponsor

Institute of Skin and Product Evaluation, Italy is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

  • Active comparator
    Omega7 Cream

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

    Other: Omega7 Sea Buckthorn Oil Cream

  • Placebo comparator
    Base cream

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

    Other: Base cream

Interventions

  • OtherOmega7 Sea Buckthorn Oil Cream

    The subjects use Omega7 Sea Buckthorn Oil Cream on the face, twice per day

  • OtherBase cream

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

  • Dietary supplementSBA24 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.

    Also known as: Omega7/Membrasin Capsule, Omega7 Cream

  • Dietary supplementSBA24 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

    Also known as: Omega7/Membrasin/SBA24 Sea Buckthorn Oil Capsule

06

What researchers measure

Primary outcomes

  1. Decrease of signs of skin aging

    Time frame: 8 weeks

Secondary outcomes

  1. Subjects self-assessment of the efficacy of the treatment

    Time frame: 8 weeks

07

Study locations

1 site
  • ISPE Srl
    Milan, 20125, Italy
    • Adriana Bonfigli, PhD · Contacta.bonfigli@ispe.it · +39 0267100695/+39 0267100703
    • Adriana Bonfigli, PhD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2008, a primary completion of Nov 2008 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2008
First posted
Oct 6, 2008
Start
Oct 2008
Primary completionEst.
Nov 2008
CompletionEst.
Dec 2008
Last update
Oct 6, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 6, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00767156
Lead sponsor
Institute of Skin and Product Evaluation, Italy
Collaborators
Aromtech Ltd.
First posted
Oct 6, 2008
Start date
Oct 2008
Primary completion
Nov 2008 (estimated)
Completion
Dec 2008 (estimated)
Last update
Oct 6, 2008

Study contacts

Adriana Bonfigli, PhD
principal investigator · Research Director

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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