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Assessment of Needs of Moisturizers After Various Laser Treatments

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ClinicalTrials.gov Identifier: NCT01742247
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Pusan National University Hospital

Tracking Information
First Submitted Date  ICMJE December 3, 2012
First Posted Date  ICMJE December 5, 2012
Last Update Posted Date March 30, 2016
Study Start Date  ICMJE September 2012
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2012)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)		 Clinical assessment of erythema, transepidermal water loss [ Time Frame: 2weeks ]
The clinical assessement of erythema, pigmentation, transepidermal water loss will be evaluated by using apparatus.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Needs of Moisturizers After Various Laser Treatments
Official Title  ICMJE Phase 4 Study of Assessment of Needs of Moisturizers After Various Laser Treatment
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Dermatologic Disorders
  • Injury Due to Laser
Intervention  ICMJE
  • Other: Physiogel
    Application of moisturizer on laser-treated area
    Other Names:
    • Other moisturizer: Palmitoylethanolamide
    • Other Names:Physiogel
  • Other: Moisturizer
    Application of moisturizer on laser-treated area
    Other Names:
    • Other moisturizer: Palmitoylethanolamide
    • Other Names:Physiogel
Study Arms  ICMJE Experimental: Physiogel, Laser therapy, Moisturizer

Experimental: Physiogel treated & Non-treated

1 Palmitoylethanolamide, Physiogel 3 times a day for 2 weeks

Interventions:
  • Other: Physiogel
  • Other: Moisturizer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2012)		 20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01742247
Other Study ID Numbers  ICMJE PNUHDM-laser and moisturizers
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Pusan National University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pusan National University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Byung-Soo Kim, Ph.D. Pusna National University Hospital
PRS Account Pusan National University Hospital
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP