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Clinical Trials/NCT00818467
NCT00818467CompletedPhase 4

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

Creighton University1 site in 1 country50 target enrollmentStarted: May 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
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.

Study Overview

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?

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • Not provided

Arms & Interventions

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.

Intervention: Tanning spray (Other)

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.

Intervention: UVB (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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