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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01892150
First received: May 23, 2013
Last updated: March 27, 2014
Last verified: March 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    Review difference in H&E staining in tissue biopsy before and after UVA / UVB irradiation


Secondary Outcome Measures:
  • Tyrosinase Staining [ Time Frame: 2 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   35 Years to 65 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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)
Study First Received: May 23, 2013
Last Updated: March 27, 2014
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014