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A Capacitance and Transepidermal Water Loss Test to Determine the Ability of Sunscreen to Moisturize Skin

This study is currently recruiting participants.
Verified by Loreal USA, July 2006

Sponsored by: Loreal USA
Information provided by: Loreal USA
ClinicalTrials.gov Identifier: NCT00368563
  Purpose

To evaluate the ability of 2 Helioblock SX Cream formulations to moisturize skin using capacitance and transepidermal water loss methodology


Condition Intervention Phase
Dry Skin
Drug: Helioblock SX
Phase II
Phase III

MedlinePlus related topics:   Drinking Water   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Randomized, Single Blind, Uncontrolled, Single Group Assignment
  Eligibility
Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both

Criteria

Inclusion Criteria:

  • Healthy,male or female subjects 18 years to 55 years of age, with a minimum Stanfield score at baseline of "2" at the forearm sites intended to be assessed in the study
  • Female subjects of childbearing potential using a reliable form of contraception during the course of the study(oral contraceptive pill, intrauterine device, bilateral tubal ligation, abstinence, or other reliable forms at the discretion of the Investigator.) or of non childbearing potential(i.e.,post-menopausal(one year without menstrual period), hysterectomy or bilateral ovariectomy)
  • Subjects who have read, understood and signed an informed consent
  • Subjects who are willing and capable of cooperating to the extent and degree required by the protocol
  • Absence of any visible skin diseases which might be confused with a skin reaction from the test material

Exclusion Criteria:

  • Subjects with a condition, or in a situation, which in the Investigator's or Sub-Investigator's opinion, may suggest a significant hazard for the subject, may confound the study results, or may interfere with the subject's participation in the study.
  • Subjects with known sensitivities to any of the study preparations or to other skin care products
  • Subjects who have participated in a clinical research study, including consumer products studies, within the last 30 days prior to enrollment
  • Subjects who are currently receiving medication(prescription or OTC) that in the opinion of the Investigator may interfere with the evaluations made in this study (e.g.vasoactive substances)
  • Pregnant or nursing females or women who are planning to get pregnant during the study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368563

Contacts
Contact: Jennifer Mann, B.A.     480-949-7766 ext 240    

Locations
United States, Arizona
Hill Top Research     Recruiting
      Scottsdale, Arizona, United States, 85251
      Contact: Jennifer Mann, B.A.     480-949-7766 ext 240        

Sponsors and Collaborators
Loreal USA

Investigators
Principal Investigator:     Linda Oddo, B.S.     Hill Top Research    
  More Information

Study ID Numbers:   PEN.1010.02
First Received:   August 23, 2006
Last Updated:   August 23, 2006
ClinicalTrials.gov Identifier:   NCT00368563
Health Authority:   United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 04, 2008




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