Eczema sufferers with dry skin. MedDRA version: 12.0 Level: HLT Classification code 10012435 Term: Dermatitis and eczema
Conditions
Interventions
Product Name: DELP Gel
Product Code: DELP
Pharmaceutical Form: Gel
Other descriptive name: Liquid Paraffin EP
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration
Sponsors
Dermal Laboratories Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PR1 is a modified version of the sponsor's licenced emollient, PR2. The skin emollient and hydrating properties of PR1 will hopefully last for longer than PR2. This would be a therapeutic advantage because many patients cannot re-apply their emollients as often as ideally necessary. Part 1 The primary objective in part 1 is to compare the two emollients in terms of the effect, of a single application, on skin moisturisation levels over a 24 hour period. Part 2 The primary objective in part 2 is to compare the two emollients in terms of their cumulative effects on skin moisturisation levels when applied twice daily over 5 consecutive days. ;Secondary Objective: The secondary objective is to compare the cosmetic acceptability of the two products. ;Primary end point(s): The primary endpoint in Part 1 of the study is the difference in effect on skin moisturisation between the test products, following a single application of the emollients. The primary endpoint in Part 2 of the study is the difference in effect on skin moisturisation between the test products, following 2 consecutive days of twice daily applications of the emollients. | — |
Countries
United Kingdom
Outcome results
None listed