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Histologic Response to UVA and UVB Exposure During the Use of Sunscreen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01892150
First Posted: July 4, 2013
Last Update Posted: March 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mahidol University
  Purpose
Anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen. However, there is no histologic study about the effects of anti-inflammatory and anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.

Condition Intervention
Solar Elastosis Other: Sunscreen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Histologic Response to UVA and UVB Exposure During the Use of Sunscreen With Anti-inflammatory and Anti-oxidant Properties - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • H&E Staining [ Time Frame: 2 Months ]
    Review difference in H&E staining in tissue biopsy before and after UVA / UVB irradiation


Secondary Outcome Measures:
  • Tyrosinase Staining [ Time Frame: 2 Months ]
    Review difference in Tyrosinase staining in tissue biopsy before and after UVA / UVB irradiation to evaluate the effects of pigment darkening after UV exposure


Other Outcome Measures:
  • 8-OH-dG Staining [ Time Frame: 2 Months ]
    Review difference in 8-OH-dG staining in tissue biopsy before and after UVA / UVB irradiation to evaluate the quantity of free radical species after UV exposure

  • MMP1 Staining [ Time Frame: 2 Months ]
    Review difference in MMP1 staining in tissue biopsy before and after UVA / UVB irradiation to evaluate the collagen and ground substances destruction after UV exposure


Enrollment: 2
Study Start Date: March 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunscreen
Apply sunscreen before and after UVA and UVB irradiation
Other: Sunscreen
Apply sunscreen before and after UVA and UVB irradiation

Detailed Description:
Premature aging can be prevented by using sunscreen. Currently, anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen. However, there is no histologic study about the effects of anti-inflammatory and anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • subjects aged 35-65 years who were scheduled for abdominoplasty
  • the excised area should be larger than 18x10 cm2
  • no skin diseases or lesions on the excised area
  • no topical treatment on excised area more than 1 month prior to this study

Exclusion Criteria:

  • pregnancy
  • lactation
  • have tattoo or striae distensae on abdomen
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892150


Locations
Thailand
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Rungsima Wanitphakdeedecha, MD, MA, MSc Mahidol University
  More Information

Publications:
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01892150     History of Changes
Other Study ID Numbers: Siriraj-Eucerin02
721/2555(EC2) ( Other Identifier: Siriraj Institutional Review Board )
First Submitted: May 23, 2013
First Posted: July 4, 2013
Last Update Posted: March 31, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents