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

Tracking Information

First Received Date ^ICMJE

August 23, 2006

Last Updated Date

February 10, 2009

Start Date ^ICMJE

August 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00368563 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Single Blind, Uncontrolled, Single Group Assignment

Condition ^ICMJE

Dry Skin

Intervention ^ICMJE

Drug: Helioblock SX

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00368563

Responsible Party

Study ID Numbers ^ICMJE

PEN.1010.02

Study Sponsor ^ICMJE

Loreal USA

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Linda Oddo, B.S.

Hill Top Research

Information Provided By

Loreal USA

Verification Date

February 2009

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