Dry or chapped skin conditions which may also be pruritic (itchy) or inflamed e.g. eczema, psoriasis, elderly pruritus and dermatitis.
Conditions
Interventions
Pharmaceutical Form: Gel
INN or Proposed INN: isopropyl myristate
CAS Number: 110-27-0
Concentration unit: % (W/W) percent weight/weight
Sponsors
Dermal Laboratories Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients, upwards of 13 years of age and who normally shower, presenting to their GP with a dry and pruritic skin condition such as eczema, psoriasis, elderly pruritus or dermatitis, and currently receiving prescribed emollient treatment, either alone or as an adjunct to other topical pharmaco-therapy, will be eligible for inclusion. Are the trial subjects under 18? yes 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i) Patients less than 13 years old. ii) Patients older than 13 years but ‘incompetent’ to perform the evaluations. iii) Patients who do not normally shower. iv) Patients with acute, weeping or infected dermatoses. v) Patients with a history of known or suspected intolerance or skin sensitivity to products administered topically, whether cosmetics, toiletries or pharmaceuticals, unless such is known to be attributed to ingredients not present in the study emollient. vi) Patients who have received any unlicensed drug within the last 30 days or who are scheduled to receive an investigative drug other than the study medication during the period of the study. vii) Patients with systemic diseases which, in the opinion of the investigator, may adversely influence their participation in the trial. viii) Female patients who are pregnant, lactating or trying to become pregnant (although there are no particular safety concerns in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification). ix) Patients considered unable or unlikely to attend the necessary follow-up consultation. x) Patients who themselves, or whose parent/guardian, are considered unlikely to understand the patient information leaflet which is to be written only in English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the trial is to confirm the product's effectiveness and cosmetic acceptability when used by patients with medically dry skin in the normal clinical situation. ;Secondary Objective: Secondary objectives will be to assess the patients’ opinion of the new shower container, and their understanding of the Patient Information Leaflet, in particular, with respect to the instructions for use and safety information.; Primary end point(s): The primary endpoints will be the patients’ i. assessment of the performance of the shower gel in terms of four characteristics : skin smoothness, softness, lack of dryness and lack of itchiness. ii. assessment of the cosmetic acceptability of the shower gel in terms of four attributes: texture/feel, lack of fragrance, cleaning action and lack of greasiness. | — |
Countries
United Kingdom
Outcome results
None listed