Assessment of Needs of Moisturizers After Various Laser Treatments
Primary Purpose
Dermatologic Disorders, Injury Due to Laser
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Physiogel
Moisturizer
Sponsored by
About this trial
This is an interventional prevention trial for Dermatologic Disorders focused on measuring Moisturizer, laser
Eligibility Criteria
Inclusion Criteria:
- at least 18 years of age without any dermatologic diseases
Exclusion Criteria:
- 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
Sites / Locations
- Department of dermatology, Pusan National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physiogel, Laser therapy, Moisturizer
Arm Description
Experimental: Physiogel treated & Non-treated 1 Palmitoylethanolamide, Physiogel 3 times a day for 2 weeks
Outcomes
Primary Outcome Measures
Clinical assessment of erythema, transepidermal water loss
The clinical assessment of erythema, pigmentation, transepidermal water loss will be evaluated by using apparatus.
Secondary Outcome Measures
Full Information
NCT ID
NCT01742247
First Posted
December 3, 2012
Last Updated
March 29, 2016
Sponsor
Pusan National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01742247
Brief Title
Assessment of Needs of Moisturizers After Various Laser Treatments
Official Title
Phase 4 Study of Assessment of Needs of Moisturizers After Various Laser Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pusan National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatologic Disorders, Injury Due to Laser
Keywords
Moisturizer, laser
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physiogel, Laser therapy, Moisturizer
Arm Type
Experimental
Arm Description
Experimental: Physiogel treated & Non-treated
1 Palmitoylethanolamide, Physiogel 3 times a day for 2 weeks
Intervention Type
Other
Intervention Name(s)
Physiogel
Other Intervention Name(s)
Other moisturizer: Palmitoylethanolamide, Other Names:Physiogel
Intervention Description
Application of moisturizer on laser-treated area
Intervention Type
Other
Intervention Name(s)
Moisturizer
Other Intervention Name(s)
Other moisturizer: Palmitoylethanolamide, Other Names:Physiogel
Intervention Description
Application of moisturizer on laser-treated area
Primary Outcome Measure Information:
Title
Clinical assessment of erythema, transepidermal water loss
Description
The clinical assessment of erythema, pigmentation, transepidermal water loss will be evaluated by using apparatus.
Time Frame
2weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
at least 18 years of age without any dermatologic diseases
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Soo Kim, Ph.D.
Organizational Affiliation
Pusna National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of dermatology, Pusan National University Hospital
City
Busan
Country
Korea, Republic of
12. IPD Sharing Statement
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Assessment of Needs of Moisturizers After Various Laser Treatments
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