NCT00785187

Brief Summary

Purpose of study: Evaluation of the affect of dose rate on UVR induced skin erythema. Study design: A single-center, prospective, randomized, crossover, open study. Number of patients: 20-40 Patient population: Healthy volunteers Control: Different sites on patients body Procedure duration: Total 3-5 hours (4 visits) Duration of follow up: 4 days Duration of study: Up to 6 months Primary objectives: To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
26 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Last Updated

November 5, 2008

Status Verified

November 1, 2008

Enrollment Period

2 months

First QC Date

November 3, 2008

Last Update Submit

November 4, 2008

Conditions

Erythema

Keywords

UVB induced skin erythema

Outcome Measures

Primary Outcomes (1)

  • To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10

    end of study

Interventions

exposure to UVB radiationDEVICE

exposure to UVB radiation for limited time in order to establish subject's minimal erythema dose.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Fitzpatrick Skin types I-III.
  • Age 18-60.
  • Absence of obvious sun damage on the volar side of the forearm or other exposure sites.
  • Absence of exposure of the arms or other exposure sites to sunlight for two weeks prior to the experiment.

You may not qualify if:

  • History of skin cancer.
  • Multiple nevi or atypical nevi on the forearm.
  • Signs of sun damage on the volar side of the forearm or other exposure sites.
  • Mentally incompetent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDIV

Study Record Dates

First Submitted

November 3, 2008

First Posted

November 5, 2008

Study Start

December 1, 2008

Primary Completion

February 1, 2009

Last Updated

November 5, 2008

Record last verified: 2008-11