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

Solar Elastosis Clinical Trial

Official title:

Histologic Response to UVA and UVB Exposure During the Use of Sunscreen With Anti-inflammatory and Anti-oxidant Properties - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892150
• Other study ID #: Siriraj-Eucerin02
• Secondary ID: 721/2555(EC2)
• Status: Completed
• Phase: N/A
• First received: May 23, 2013
• Last updated: March 27, 2014
• Start date: March 2013
• Est. completion date: July 2013

Study information

• Verified date: March 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Solar Elastosis

Intervention

Other:
• Sunscreen
Apply sunscreen before and after UVA and UVB irradiation

Locations

Country	Name	City	State
Thailand	Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Lavker RM, Gerberick GF, Veres D, Irwin CJ, Kaidbey KH. Cumulative effects from repeated exposures to suberythemal doses of UVB and UVA in human skin. J Am Acad Dermatol. 1995 Jan;32(1):53-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	8-OH-dG Staining	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	No
Other	MMP1 Staining	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	No
Primary	H&E Staining	Review difference in H&E staining in tissue biopsy before and after UVA / UVB irradiation	2 Months	No
Secondary	Tyrosinase Staining	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	No