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.

Dermal Laboratories Ltd0 sites40 target enrollmentMarch 17, 2010

Overview

Phase: Not Applicable
Intervention: Not specified
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.
Sponsor: Dermal Laboratories Ltd
Enrollment: 40
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

March 17, 2010

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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.