Dermatologic DisordersPhase 4NCT01742247
Assessment of Needs of Moisturizers After Various Laser Treatments
A Phase 4 study testing Physiogel and Moisturizer in people with Dermatologic Disorders and Injury Due to Laser, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
Assessment of needs of moisturizers after various laser treatments Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatologic Disorders, Injury Due to Laser
- What is being tested?
- Physiogel and Moisturizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Dec 2015
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 18 years of age without any dermatologic diseases
Who cannot join
- Taking other known dermatologic disease
- Others who are shown pigmented lesion on treated-area
- Who have allergy or history of hypersensitivity reaction to moisturizers
- Who have other definitive cutaneous findings
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of dermatology, Pusan National University Hospital
Busan, Busan
About this study
Official title: Phase 4 Study of Assessment of Needs of Moisturizers After Various Laser Treatment
Assessment of needs of moisturizers after various laser treatments
Read the detailed description
The investigators would like to assess of needs of moisturizers after various laser treatment
: by investigating the changes in the skin barrier function after fractional carbon dioxide laser and fractional Er:Glass laser in mice and human skin
- Conditions
- Dermatologic Disorders, Injury Due to Laser
- Being tested
- Physiogel, Moisturizer
- Keywords
- Moisturizer, laser
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiogelOther
Also called Other moisturizer: Palmitoylethanolamide, Other Names:Physiogel
Application of moisturizer on laser-treated area
MoisturizerOther
Also called Other moisturizer: Palmitoylethanolamide, Other Names:Physiogel
Application of moisturizer on laser-treated area
| Study group | Role | What they receive |
|---|---|---|
| Physiogel, Laser therapy, Moisturizer | Experimental | Experimental: Physiogel treated \& Non-treated
1 Palmitoylethanolamide, Physiogel 3 times a day for 2 weeks Receives: Other: Physiogel; Other: Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of erythema, transepidermal water loss
The clinical assessment of erythema, pigmentation, transepidermal water loss will be evaluated by using apparatus.
Measured: 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatologic DisordersStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byung-Soo Kim, Ph.D., Study chair, Pusna National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742247
- Sponsor's protocol ID
- PNUHDM-laser and moisturizers
- Status last verified
- Mar 2016
- First submitted
- 3 Dec 2012
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Assessment of Needs of Moisturizers After Various Laser Treatment
- ClinicalTrials.gov ID
- NCT01742247
- Acronym / sponsor ID
- PNUHDM-laser and moisturizers
- Conditions
- Dermatologic Disorders, Injury Due to Laser
- Keywords
- Moisturizer, laser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Dec 2012 (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.
Assessment of needs of moisturizers after various laser treatments
Detailed description
The investigators would like to assess of needs of moisturizers after various laser treatment
: by investigating the changes in the skin barrier function after fractional carbon dioxide laser and fractional Er:Glass laser in mice and human skin
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiogel, Laser therapy, Moisturizer | Experimental | Other: Physiogel, Other: MoisturizerExperimental: Physiogel treated \& Non-treated 1 Palmitoylethanolamide, Physiogel 3 times a day for 2 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- at least 18 years of age without any dermatologic diseases
Key exclusion criteria (4 listed)
- Taking other known dermatologic disease
- Others who are shown pigmented lesion on treated-area
- Who have allergy or history of hypersensitivity reaction to moisturizers
- Who have other definitive cutaneous findings
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 |
|---|---|---|
| PhysiogelAlso: Other moisturizer: Palmitoylethanolamide, Other Names:PhysiogelApplication of moisturizer on laser-treated area | Other | Physiogel, Laser therapy, Moisturizer |
| MoisturizerAlso: Other moisturizer: Palmitoylethanolamide, Other Names:PhysiogelApplication of moisturizer on laser-treated area | Other | Physiogel, Laser therapy, Moisturizer |
Primary outcome
Clinical assessment of erythema, transepidermal water loss
Time frame: 2weeks
The clinical assessment of erythema, pigmentation, transepidermal water loss will be evaluated by using apparatus.
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 30 Mar 2016.
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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.
Byung-Soo Kim, Ph.D. study chair
Pusna National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Physiogel and Moisturizer in people with Dermatologic Disorders and Injury Due to Laser, run by Pusan National University Hospital at 1 site in South Korea.
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 4 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 30 Mar 2016. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical assessment of erythema, transepidermal water loss (time frame: 2weeks). 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 30 Mar 2016.