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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00818467
Other study ID # Creighton 7
Secondary ID
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


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
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