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

Dry Skin Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368563
• Other study ID #: PEN.1010.02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 23, 2006
• Last updated: February 10, 2009
• Start date: August 2006
• Est. completion date: October 2006

Study information

• Verified date: February 2009
• Source: Loreal USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Dry Skin

Intervention

Drug:
• Helioblock SX

Locations

Country	Name	City	State
United States	Hill Top Research	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Loreal USA

Country where clinical trial is conducted

United States,