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UVB Light and Sunscreen

This study has been completed.
Sponsor:
Collaborator:
The UV Foundation
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00818467
First received: January 6, 2009
Last updated: November 27, 2009
Last verified: November 2009
  Purpose

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?


Condition Intervention Phase
Vitamin D Status
Other: Tanning spray
Other: UVB
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 3% Dihydroxyacetone (DHA or Sunless Tanning Agent) Inhibits Vitamin D Production in the Skin in Response to Ultraviolet Light

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818467

Locations
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
The UV Foundation
Investigators
Principal Investigator: Laura A Armas, MD Creighton University
  More Information

No publications provided

Responsible Party: Laura Armas, Creighton University
ClinicalTrials.gov Identifier: NCT00818467     History of Changes
Other Study ID Numbers: Creighton 7
Study First Received: January 6, 2009
Last Updated: November 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Skin tone
Vitamin D

ClinicalTrials.gov processed this record on November 20, 2014