Atopic dermatitis. MedDRA version: 14.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Doublebase Dayleve Gel
Pharmaceutical Form: Gel
INN or Proposed INN: Isopropyl Myristate
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 1
Sponsors
Dermal Laboratories
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients, 2 years of age and upwards, presenting to their GP with atopic dermatitis requiring regular emollient treatment, either alone or as an adjunct to other topical pharmacotherapy will be eligible to take part in the study. Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: Patients falling into any of the following categories will not be eligible to take part in the study: i) Less than 2 years old. ii) Acute, weeping or infected dermatoses. iii) Dermatoses considered by the investigator likely to require treatment with antibiotics or immunosuppressants within the next 2 weeks. iv) Other dry skin condition such as contact dermatitis or psoriasis. v) 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) Having received any unlicensed drug within the last 30 days or scheduled to receive an investigative drug other than the study medication during the period of the study. vii) Systemic diseases which, in the opinion of the investigator, may adversely influence participation in the trial. viii) Use of oral steroids, immunosuppressants or antibiotics to treat their skin condition within the last 14 days. ix) Females who are pregnant or lactating (although there are no particular safety concerns for DELP in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification). x) Considered unable or unlikely to attend the necessary follow-up consultation. xi) Considered unlikely to understand the patient information leaflet which is to be written only in English. xii) Having another member of the household already participating in the study (because they may end up using the same pack of emollient or inadvertently swapping packs in which case estimates of the quantities used by each subject would be unreliable).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the study is to obtain patients’ feedback on the product’s cosmetic acceptability and performance/usefulness when used as part of normal standard care for the intended patient group. The additional, exploratory objectives are to assess the cosmetic acceptability and performance/usefulness of the gel in comparison to previous emollients if the patients have used an emollient within the previous year.;Secondary Objective: Not applicable.;Primary end point(s): There will be no primary outcome measure as such. The endpoints for the study are the patients' assessment of; i) the cosmetic acceptability of DELP (4 parameters) ii) the performance/usefulness of DELP (8 parameters) For those patients who have used prescribed emollients previously for their atopic dermatitis, additional exploratory endpoints will include their assessments of the cosmetic acceptability and performance/usefulness of DELP when compared to that of their previous emollient (13 parameters).;Timepoint(s) of evaluation of this end point: The endpoint will be measured following 14 days of use of the product. | — |
Countries
United Kingdom
Contacts
Public ContactKrystyna Sykes
Dermal Laboratories
Outcome results
None listed