- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01892150
Histologic Response to UVA and UVB Exposure During the Use of Sunscreen
March 27, 2014 updated by: Mahidol University
Histologic Response to UVA and UVB Exposure During the Use of Sunscreen With Anti-inflammatory and Anti-oxidant Properties - A Pilot Study
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bangkok, Thailand, 10700
- Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Sunscreen
Apply sunscreen before and after UVA and UVB irradiation
|
Apply sunscreen before and after UVA and UVB irradiation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
H&E Staining
Time Frame: 2 Months
|
Review difference in H&E staining in tissue biopsy before and after UVA / UVB irradiation
|
2 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 Months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 Months
|
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
|
2 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rungsima Wanitphakdeedecha, MD, MA, MSc, Mahidol University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (ACTUAL)
July 1, 2013
Study Completion (ACTUAL)
July 1, 2013
Study Registration Dates
First Submitted
May 23, 2013
First Submitted That Met QC Criteria
June 30, 2013
First Posted (ESTIMATE)
July 4, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
March 31, 2014
Last Update Submitted That Met QC Criteria
March 27, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Siriraj-Eucerin02
- 721/2555(EC2) (OTHER: Siriraj Institutional Review Board)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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