UVB Light and Sunscreen (Sunscreen)

November 27, 2009 updated by: Creighton University

3% Dihydroxyacetone (DHA or Sunless Tanning Agent) Inhibits Vitamin D Production in the Skin in Response to Ultraviolet Light

Patients need vitamin D which is normally produced in the skin in response to ultraviolet light from the sun. Vitamin D is important for calcium absorption and good bone health. Physicians have been using sunscreens to protect patients from skin cancer and the aging effects of sunlight for a least a half a century. Dermatologists have promoted sunscreen use to restrict sunlight exposure especially in white Caucasians. If this behavior is done 100% of the time when outdoors individuals may suffer from vitamin D deficiency. It is impossible to influence persons' behavior to wear sunscreens all the time when outdoors. With the use of sunless tanning agent (DHA), once a week, we can obtain a continuous sunscreen in the top layer of the skin that will not wash off, can't be removed with soap and water, or removed by perspiration. Under these circumstances we can answer the scientific question, will sunscreen use inhibit the production of vitamin D in the skin?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

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

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton 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

19 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • males or females
  • ages 19-50 with less than 16 oz milk per day
  • less than 10 hours of sun per week
  • no Vitamin D supplements
  • no anticonvulsants
  • no barbiturates
  • no steroids
  • no meds that increase photosensitivity
  • no granulomatous disease
  • no liver or kidney disease
  • no history of skin cancer
  • BMI less than 30
  • skin types I & II

Exclusion Criteria:

  • None

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tanning spray
To characterize the 25(OH)D response to 4 weeks of thrice weekly 40 mJ of UV-B light in a group of normal subjects with skin types I and II while using multiple applications of 3% DHA for five weeks.
Other: Tanning spray
using 3% DHA twice a week for the 1st week and then once a week for 4 weeks and receiving 40mJ UV-B phototherapy three times a week for four weeks
Active Comparator: UVB
To characterize the 25(OH)D response to 4 weeks of thrice weekly 40 mJ of UV-B light in a control group of normal subjects with skin types I and II who are not using 3% DHA applications.
Other: UVB
receiving 40mJ UV-B phototherapy three times a week for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure the response of 25(OH)D to 40 milliJoules of UV-B light in white Caucasians with melanoidins-sunscreen from 3% DHA in comparison to the response of control subjects who have not used 3% DHA.
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Collaborators

The UV Foundation

Investigators

  • Principal Investigator: Laura A Armas, MD, Creighton University

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

May 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

December 1, 2009

Last Update Submitted That Met QC Criteria

November 27, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Creighton 7

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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