NCT00767156

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 6, 2008

Status Verified

October 1, 2008

Enrollment Period

1 month

First QC Date

October 3, 2008

Last Update Submit

October 3, 2008

Conditions

Skin Aging

Keywords

Sea buckthorn oil, Oral and topical treatment, Skin aging

Outcome Measures

Primary Outcomes (1)

  • Decrease of signs of skin aging

    8 weeks

Secondary Outcomes (1)

  • Subjects self-assessment of the efficacy of the treatment

    8 weeks

Study Arms (4)

SBA24 capsule plus Omega7 cream

ACTIVE COMPARATOR

the subjects took SBA24 sea buckthorn oil capsule and apply Omega7 cream

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

Dietary Supplement: SBA24 Sea Buckthorn Oil Capsule

Omega7 Cream

ACTIVE COMPARATOR

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

Other: Omega7 Sea Buckthorn Oil Cream

Base cream

PLACEBO COMPARATOR

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

Other: Base cream

Interventions

Omega7 Sea Buckthorn Oil CreamOTHER

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

Omega7 Cream
Base creamOTHER

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

Base cream
SBA24 Sea Buckthorn Oil CapsuleDIETARY_SUPPLEMENT

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
SBA24 capsule plus Omega7 cream

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISPE Srl

Milan, 20125, Italy

Location

Study Officials

  • Adriana Bonfigli, PhD

    Research Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

October 6, 2008

Record last verified: 2008-10

Locations

IT(1)