UVB Light and Sunscreen

NCT00818467 | Completed Phase 4

• 1 other identifier: Creighton 7
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Vitamin D Status

Keywords

Skin tone; Vitamin D

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tanning spray

EXPERIMENTAL

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

UVB

ACTIVE COMPARATOR

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

Interventions

Tanning spray OTHER

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

Tanning spray

UVB OTHER

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

UVB

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Creighton University: lead
• The UV Foundation: collaborator

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

Study Officials

• Laura A Armas, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 7, 2009
• Study Start: May 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 1, 2009

Record last verified: 2009-11

Locations

US (1)