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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
Pusan National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dermatologic Disorders focused on measuring Moisturizer, laser

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
December 3, 2012
Last Updated
March 29, 2016
Sponsor
Pusan National University Hospital
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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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