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Sunless Tanning Products as a Substitute for Sunbathing in Healthy Participants

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: UMASS Memorial Cancer Center - University Campus
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00403377
  Purpose

RATIONALE: Understanding why sunbathers use or don't use sunless tanning products may help doctors plan effective ways to prevent skin cancer caused by sunbathing.

PURPOSE: This phase I/II trial is studying attitudes about the use of sunless tanning products and how well sunless tanning products work as a substitute for sunbathing in healthy participants.


Condition Intervention Phase
Melanoma (Skin)
Non-Melanomatous Skin Cancer
Drug: sunless tanning lotion
Drug: sunscreen lotion
Procedure: counseling
Procedure: screening questionnaire administration
Phase I
Phase II

MedlinePlus related topics:   Cancer    Melanoma    Skin Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Open Label, Active Control
Official Title:   Investigation of a Behavioral Substitute for Sunbathing

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them (Phase I) [ Designated as safety issue: No ]
  • Opinions, suggestions, and preferences regarding use of sunless tanning products (Phase I) [ Designated as safety issue: No ]
  • Time spent sunbathing in random beach-goers at 2 and 12 months (Phase II) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sunburn frequency in random beachgoers at 2 and 12 months (Phase II) [ Designated as safety issue: No ]
  • Use of a sunless tanner in random beach-goers at 2 and 12 months (Phase II) [ Designated as safety issue: No ]
  • Perceptions of sun protection, susceptibility to photoaging, benefits of sunbathing, and severity of photoaging in random beach-goers at 2 and 12 months (Phase II) [ Designated as safety issue: No ]

Estimated Enrollment:   330
Study Start Date:   April 2006

Detailed Description:

OBJECTIVES:

Primary

  • Determine participants' attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them. (Phase I)
  • Determine participants' opinions, suggestions, and preferences regarding use of sunless tanning products. (Phase I)
  • Determine the validity and reliability of the Sunless Tanning Attitudes Survey.
  • Determine time spent sunbathing in random beach-goers. (Phase II)

Secondary

  • Determine sunburn frequency in random beach-goers. (Phase II)
  • Determine the use of a sunless tanner in these participants. (Phase II)
  • Determine sun protection use in these participants. (Phase II)
  • Determine perceptions of sun protection, susceptibility to photoaging, benefits of sunbathing, and severity of photoaging. (Phase II)

OUTLINE: This is an open-label phase I study followed by a pilot, randomized, controlled phase II study.

  • Phase I (focus group): Participants complete the Sunless Tanning Attitudes (STA) survey, Sun Behavior (SB) survey, and the Decisional Balance for Sun Exposure and Sun Protection Questionnaire. Participants who have used a sunless tanner in the past also complete the Sunless Tanner Users (STU) survey. Participants receive sunless tanning lotion and instructions for its use. Participants are instructed to use the sunless tanner for 2 weeks (≥ 3 applications). Participants then complete the STA, SB, and STU surveys and participate in a focus group.
  • Phase II:Participants are stratified by beach location and randomized to 1 of 2 intervention arms.

    • Arm I: Participants complete surveys as in phase I. Photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer.
    • Arm II: Participants complete surveys as in phase I. A souvenir photograph is taken of the participants and they then receive product samples that are irrelevant to skin cancer risk reduction (e.g., skin moisturizer, hair gel, chewing gum). Participants also receive educational materials at the completion of the study.

In both arms, participants complete surveys again at 2 and 12 months.

PROJECTED ACCRUAL: A total of 330 participants will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

DISEASE CHARACTERISTICS:

  • Self-described sun bather (phase I)

    • Intentional sun exposure lasting ≥ 1 hour to get a tan (outside or via tanning salon) at least twice a month during the months of June to August of the prior year
    • Intends to continue tanning during the coming summer months
  • Random beach-goer (phase II)

PATIENT CHARACTERISTICS:

  • Female
  • Must speak English
  • Must be able to read at the 6th grade level

PRIOR CONCURRENT THERAPY:

  • No prior sunless tanning products (phase II)

    • Patients enrolled in phase I may or may not have used sunless tanning products
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403377

Locations
United States, Massachusetts
UMASS Memorial Cancer Center - University Campus    
      Worcester, Massachusetts, United States, 01655

Sponsors and Collaborators
UMASS Memorial Cancer Center - University Campus
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Sherry L. Pagoto, PhD     UMASS Memorial Cancer Center - University Campus    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000499830, UMASS-MCC-H-12102, UMASS-MCC-H-11924
First Received:   November 21, 2006
Last Updated:   May 23, 2008
ClinicalTrials.gov Identifier:   NCT00403377
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
melanoma  
basal cell carcinoma of the skin  
squamous cell carcinoma of the skin  

Study placed in the following topic categories:
Skin Diseases
Squamous cell carcinoma
Carcinoma, Basal Cell
Healthy
Skin Neoplasms
Melanoma
Carcinoma
Neuroendocrine Tumors
Epidermoid carcinoma
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Carcinoma, squamous cell
Neuroepithelioma
Nevus
Carcinoma, Squamous Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 03, 2008




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