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

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

Study Overview

• Status: Completed
• Conditions: Dry Skin
• Intervention / Treatment: Drug: Helioblock SX

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Hill Top Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Collaborators and Investigators

• Sponsor: Loreal USA
• Investigators: Principal Investigator: Linda Oddo, B.S., Hill Top Research

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: August 23, 2006
• First Submitted That Met QC Criteria: August 23, 2006
• First Posted (Estimate): August 24, 2006

Study Record Updates

• Last Update Posted (Estimate): February 11, 2009
• Last Update Submitted That Met QC Criteria: February 10, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: PEN.1010.02