UVB Light and Sunscreen

NCT ID: NCT00818467

Last Updated: 2009-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tanning spray

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

UVB

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

UVB

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The UV Foundation

OTHER

Sponsor Role: collaborator

Creighton University

OTHER

Sponsor Role: lead

Responsible Party

Creighton University

Principal Investigators

Laura A Armas, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

Creighton University

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

Creighton 7

Identifier Type: -

Identifier Source: org_study_id