Dry SkinNCT01305057
Efficacy Test on Skin Hydration and Skin Barrier Function
A study testing Pyridoxine tri-isopalmitate in people with Dry Skin, run by Cosmos Technical Center at 1 site in Japan.
Trial summary
The effects of topically applied pyridoxine tri-isopalmitate (P-IP) which stimulates filaggrin synthesis in keratinocytes, on skin hydration and barrier function were examined. Subjects were separated into two groups to examine the effect of P-IP. Read more about this study
- Who is it for?
- Ages 33 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Skin
- What is being tested?
- Pyridoxine tri-isopalmitate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2009to Feb 2009
- 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 33 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy skin
Who cannot join
- don't use any moisturizer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Use Test on Skin Hydration and Skin Barrier Function
The effects of topically applied pyridoxine tri-isopalmitate (P-IP) which stimulates filaggrin synthesis in keratinocytes, on skin hydration and barrier function were examined. Subjects were separated into two groups to examine the effect of P-IP. Subjects were treated with P-IP formulation on one side of the face and with a placebo formulation on the other side twice daily (morning and evening) for 28 days. All subjects gave written informed consent prior to the study. The skin hydration and TEWL (transepidermal water loss) were evaluated by measuring skin surface conductance with a skin hygrometer SKICON 200EX (I.B.S. ltd., Japan) and TEWL meter AS-CT1 (ASAHI BIOMED, Tokyo, Japan), respectively.
Read the detailed description
It is expected that the long-term application of P-IP increase skin surface water contents and suppress TEWL.
- Conditions
- Dry Skin
- Being tested
- Pyridoxine tri-isopalmitate
- Keywords
- dry skin condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyridoxine tri-isopalmitateOther
2% dosage, oil-in-water emulsion, twice a day, 28 days
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of P-IP on hydration and barrier function | Experimental | Effects of P-IP on improvement of skin hydration and TEWL were examined. Receives: Other: Pyridoxine tri-isopalmitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of skin surface water content and Trans-Epidermal Water Loss (TEWL)
Subjects were treated with P-IP formulation on one side of the face and with a placebo formulation (without P-IP, oil-in-water emulsion type) on the other side twice daily (morning and evening) for 28 days. Skin surface water contents and TEWLs were measured at the time frame described above and the results were analyzed as a change from a value of before-application at each measurement.
Measured: Before application, 1 week, 2 week and 4 weeks after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startFeb 2009
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SkinStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmos Technical Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305057
- Sponsor's protocol ID
- Cosmos1
- Other IDs
- hydration-1
- Status last verified
- Feb 2011
- First submitted
- 13 Jan 2011
- Last updated
- 28 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Use Test on Skin Hydration and Skin Barrier Function
- ClinicalTrials.gov ID
- NCT01305057
- Acronym / sponsor ID
- Cosmos1
- Conditions
- Dry Skin
- Keywords
- dry skin condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cosmos Technical CenterIndustry (pharma, biotech, devices)
- Collaborators
- University of Dundee
- Study start
- Feb 2009
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 28 Feb 2011 (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 effects of topically applied pyridoxine tri-isopalmitate (P-IP) which stimulates filaggrin synthesis in keratinocytes, on skin hydration and barrier function were examined. Subjects were separated into two groups to examine the effect of P-IP. Subjects were treated with P-IP formulation on one side of the face and with a placebo formulation on the other side twice daily (morning and evening) for 28 days. All subjects gave written informed consent prior to the study. The skin hydration and TEWL (transepidermal water loss) were evaluated by measuring skin surface conductance with a skin hygrometer SKICON 200EX (I.B.S. ltd., Japan) and TEWL meter AS-CT1 (ASAHI BIOMED, Tokyo, Japan), respectively.
Detailed description
It is expected that the long-term application of P-IP increase skin surface water contents and suppress TEWL.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of P-IP on hydration and barrier function | Experimental | Other: Pyridoxine tri-isopalmitateEffects of P-IP on improvement of skin hydration and TEWL were examined. |
Who may qualify
- Ages
- 33 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy skin
Key exclusion criteria (1 listed)
- don't use any moisturizer
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 |
|---|---|---|
| Pyridoxine tri-isopalmitate2% dosage, oil-in-water emulsion, twice a day, 28 days | Other | Evaluation of P-IP on hydration and barrier function |
Primary outcome
Measurement of skin surface water content and Trans-Epidermal Water Loss (TEWL)
Time frame: Before application, 1 week, 2 week and 4 weeks after application
Subjects were treated with P-IP formulation on one side of the face and with a placebo formulation (without P-IP, oil-in-water emulsion type) on the other side twice daily (morning and evening) for 28 days. Skin surface water contents and TEWLs were measured at the time frame described above and the results were analyzed as a change from a value of before-application at each measurement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2011.
Related trials for Dry Skin
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruitingPhase 4
Cooling Eyedrops for Dry Eye
Dry Eye
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren's Syndrome
Recruiting
Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction
Wound Healing, Alveolitis of Jaw
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pyridoxine tri-isopalmitate in people with Dry Skin, run by Cosmos Technical Center at 1 site in Japan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Feb 2011. 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 Japan. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of skin surface water content and Trans-Epidermal Water Loss (TEWL) (time frame: Before application, 1 week, 2 week and 4 weeks after application). 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 28 Feb 2011.