UVB Light and Sunscreen

Vitamin D Status Clinical Trial

— Sunscreen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818467
• Other study ID #: Creighton 7
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2009
• Last updated: November 27, 2009
• Start date: May 2008
• Est. completion date: February 2009

Study information

• Verified date: November 2009
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 50 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin D Status

Intervention

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
• UVB
receiving 40mJ UV-B phototherapy three times a week for four weeks

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	The UV Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 month	No