Evaluation of a developmental ‘long lasting’ emollient in subjects with dry skin.

• Conditions: Eczema sufferers with dry skin.; MedDRA version: 12.0Level: HLTClassification code 10012435Term: Dermatitis and eczema

• Registration Number: EUCTR2008-006844-21-GB
• Lead Sponsor: Dermal Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-09
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Subjects fulfilling all the following criteria are eligible for inclusion in the study:
Eczema sufferers. Females with essentially ‘non-hairy’ arms and legs, aged between 18 and 65 years of age. Subjects with medically dry skin to arms and lower legs and with baseline corneometer measurements differing by no more than 5 units between left and right arms and legs. Subjects willing to adopt an essentially sedentary lifestyle for the duration of study involvement (i.e. those willing to refrain from participating in any sports or significant physical activity likely to necessitate showering/bathing more often than once daily). Subjects giving their written and witnessed informed consent.

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

Subjects falling into any of the following criteria will not be eligible for the study:
Subjects with any significant concurrent illness or skin disease currently involving arms or legs. Subjects with a history of skin disease or allergy relevant to the study. Subjects who have known allergies to the test products or their ingredients. Subjects using any topical or systemic medication, or drug, likely to affect the skin response to the test medicines.
Subjects showing any significant visible skin abnormality or hair growth at the test measurement sites considered likely to interfere with corneometry. Subjects who have participated in an irritation test, on the same skin sites, in the past month, or a sensitisation test, on any skin site, during the past 3 months. Females who are lactating or may be pregnant or if of childbearing potential and are not taking adequate contraceptive precautions. Subjects who are concurrently participating in any other safety or efficacy test. Subjects with any irritation, tattoos, scars or birthmarks at the test sites. Subjects not willing to refrain from removing leg hair (by shaving, waxing, depilation etc.) for at least 48 hours prior to study participation and for the duration of the study. Subjects who have used oral and topical steroids for any condition within the previous 4 weeks. Employees of RSSL Pharma or Dermal Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of such employees.

Study & Design

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