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

NCT ID: NCT00368563

Last Updated: 2009-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2006-10-31

Brief Summary

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

Conditions

Dry Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Interventions

Helioblock SX

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loreal USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Linda Oddo, B.S.

Role: PRINCIPAL_INVESTIGATOR

Hill Top Research

Locations

Hill Top Research

Scottsdale, Arizona, United States

Countries

United States

Other Identifiers

PEN.1010.02

Identifier Type: -

Identifier Source: org_study_id