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

Sponsor
Loreal USA (Industry)
Overall Status
Completed
CT.gov ID
NCT00368563
Collaborator
(none)
1
2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Helioblock SX
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single
Study Start Date :
Aug 1, 2006
Actual Primary Completion Date :
Oct 1, 2006
Actual Study Completion Date :
Oct 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Hill Top Research Scottsdale Arizona United States 85251

    Sponsors and Collaborators

    • Loreal USA

    Investigators

    • Principal Investigator: Linda Oddo, B.S., Hill Top Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00368563
    Other Study ID Numbers:
    • PEN.1010.02
    First Posted:
    Aug 24, 2006
    Last Update Posted:
    Feb 11, 2009
    Last Verified:
    Feb 1, 2009

    Study Results

    No Results Posted as of Feb 11, 2009