A study to determine the effects on stratum corneum of a clinical hand cleansing protocol comparing two antiseptic hand washes, using non-invasive instrumental methods in human volunteers.

• Conditions: o medical condition is to be investigated, as such. We are looking to avoid occupational hand dermatitis in healthcare professionals, simulated using a repeat hand wash cleansing protocol in healthy volunteers.

• Registration Number: EUCTR2009-016571-30-GB
• Lead Sponsor: Dermal Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-17
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Approximately 40 healthy, adult male and female volunteers, between the ages of 18 and 65, will be recruited into the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following will be excluded from taking part in the study:
1. Females who are pregnant or lactating or if of childbearing potential are not taking adequate contraceptive precautions (although it is generally considered inappropriate for this group to take part in trials, there are no safety concerns regarding these groups)
2. Those with a concurrent skin disease or history of skin disease or allergy relevant to the study
3. Subjects who have known allergies to the test products, the alcohol rub or to any of their ingredients
4. Subjects using any topical or systemic medication or drug likely to affect skin response
5. Subjects with any significant visible skin abnormality or excessive hair growth at the test measurement sites
6. Subjects who have participated in a test, on the same skin site, in the past month
7. Subjects who are concurrently participating in any other safety test
8. Subjects with any irritation, tattoos, scars or birthmarks at the test sites
9. Employees of RSSL Pharma or Dermal Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of an employee.
10. Subjects with any other medical condition which in the judgment of the Investigator would put the subject at unacceptable risk for participation in the study.
11. Subjects who have any other person in the same household as the subject taking part in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectives are to compare changes in skin condition: <br>a) by visual assessment of skin signs and symptoms, measured by a trained investigator; and b) by subjects’ assessments of how their skin feels. ;Secondary Objective: The secondary objectives are to compare changes in skin condition: <br>a) by skin hydration using corneometry;<br>b) by transepidermal water loss using TEWL; and<br>c) by measurement of skin pH.;Primary end point(s): The primary endpoints will be <br>a) the visual assessment of skin signs and symptoms measured by a trained investigator; and <br>b) the subjects’ assessments of how their skin feels.