NCT01892150

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

4 months

First QC Date

May 23, 2013

Last Update Submit

March 27, 2014

Conditions

Solar Elastosis

Outcome Measures

Primary Outcomes (1)

  • H&E Staining

    Review difference in H\&E staining in tissue biopsy before and after UVA / UVB irradiation

    2 Months

Secondary Outcomes (1)

  • Tyrosinase Staining

    2 Months

Other Outcomes (2)

  • 8-OH-dG Staining

    2 Months

  • MMP1 Staining

    2 Months

Study Arms (1)

Sunscreen

EXPERIMENTAL

Apply sunscreen before and after UVA and UVB irradiation

Other: Sunscreen

Interventions

SunscreenOTHER

Apply sunscreen before and after UVA and UVB irradiation

Sunscreen

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy
  • lactation
  • have tattoo or striae distensae on abdomen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Related 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. doi: 10.1016/0190-9622(95)90184-1.

    PMID: 7822517RESULT

MeSH Terms

Interventions

Sunscreening Agents

Intervention Hierarchy (Ancestors)

Radiation-Protective AgentsProtective AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesDermatologic AgentsTherapeutic UsesCosmeticsSpecialty Uses of Chemicals

Study Officials

  • Rungsima Wanitphakdeedecha, MD, MA, MSc

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2013

First Posted

July 4, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

TH(1)