Arm immersion test to compare the skin effects of routine bathing with and without the use of an emollient bath additive.

• Conditions: Eczema sufferers with dry skin.

• Registration Number: EUCTR2009-016572-78-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: Not specified

Inclusion Criteria

Approximately 12 male or female subjects between 18 and 65 years of age will be included in the study. Subjects will be required to have a history of eczema and present with dry skin on the arms and hands. Subjects will be asked to refrain from using moisturisers and moisturising soaps on arms and hands in the week prior to the study and for the duration of 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 participating in the study:
1. Subjects with any significant concurrent illness or skin disease at the test sites.
2. Subjects with a history of other skin disease or allergy relevant to the study.
3. Subjects who have known allergies to the test product or its ingredients
4. Subjects using any topical or systemic medication or drug likely to affect the skin or its response to treatment
5. Subjetcs with eczema visually differing in severity between left/right test sites
6. Subjects with any significant visible skin abnormality at the test site
7. Subjects that have participated 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
8. Females who are lactating, or are pregnant, or are likely to become pregnant during their time in the study. (There are no safety concerns at all regarding these groups using the bath additive – their exclusion is simply because it is generally considered inappropriate for them to take part in clinical trials.
9. Subjects that are currently participating in any other safety test.
10. Subjects with any irritation, tattoos, scars or birthmarks at the test sites
11. Subjects that have used any unlicensed medicine within the previous 30 days
12. Employees of RSSL Pharma or Dermal Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of an employee.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: None;Main Objective: The objective of the study is to compare, using objective instrumental efficacy endpoints, and under controlled laboratory conditions simulating normal clinical use, the effects on skin condition of repeated daily bathing in water with, and without, the addition of an emollient bath additive. ;Primary end point(s): The primary endpoints will be: skin hydration measured by corneometry; skin pH; and water loss from the skin, measured by Trans-epidermal Water Loss instrument (TEWL).