A study to compare the effects on stratum corneum of two medical hand wash formulations, using non-invasive instrumental methods in human volunteers.
- Conditions
- The study is a healthy volunteer study.
- Registration Number
- EUCTR2008-000333-22-GB
- Lead Sponsor
- Dermal Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Forty male and female volunteers shall be recruited. The volunteers shall be healthy adults, aged 18 to 65 years. Written informed consent must be obtained from volunteers who are to take part in 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
1. Females who are pregnant or lactating (although it is generally considered inappropriate for this group to take part in trials, there are no safety concerns regarding the use of either product in these groups)
2. History of skin disease or allergy relevant to the study
3. Subjects who have known allergies to the test products or their ingredients
4. Use of any topical or systemic medication or drug likely to affect skin response
5. Any significant visible skin abnormality or excessive hair growth at the test measurement sites
6. Participation in an irritation test, on the same skin site, in the past month, or a sensitisation test, on any skin site, during the past 3 months
7. Concurrent participation in any other safety test
8. 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. Any other medical condition which in the judgment of the Investigator would put the subject at unacceptable risk for participation 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 objective is to compare changes in skin condition by measurements of skin hydration, using corneometry. ;Secondary Objective: The secondary objective is to compare changes in skin condition by measurement of transepidermal water loss (TEWL), and by visual assessment of changes in skin condition (signs and symptoms).<br><br>The tertiary objective is to compare the consumer preference via questionnaire responses.;Primary end point(s): The primary endpoint will be the Corneometry measurements taken at sites on the hands and lower arms.
- Secondary Outcome Measures
Name Time Method