Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 23, 2006
February 10, 2009
August 2006
October 2006   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00368563 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Capacitance and Transepidermal Water Loss Test to Determine the Ability of Sunscreen to Moisturize Skin
Not Provided

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

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Dry Skin
Drug: Helioblock SX
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
October 2006
October 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00368563
PEN.1010.02
Not Provided
Not Provided
Loreal USA
Not Provided
Principal Investigator: Linda Oddo, B.S. Hill Top Research
Loreal USA
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP