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

This study has been completed.
Sponsor:
Information provided by:
Loreal USA
ClinicalTrials.gov Identifier:
NCT00368563
First received: August 23, 2006
Last updated: February 10, 2009
Last verified: February 2009
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind

Resource links provided by NLM:


Further study details as provided by Loreal USA:

Study Start Date: August 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Hill Top Research
Scottsdale, Arizona, United States, 85251
Sponsors and Collaborators
Loreal USA
Investigators
Principal Investigator: Linda Oddo, B.S. Hill Top Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00368563     History of Changes
Other Study ID Numbers: PEN.1010.02
Study First Received: August 23, 2006
Last Updated: February 10, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014