EUCTR2006-001509-26-GBActive, not recruitingPhase 1
An open evaluation of an emollient shower gel for dry skin conditions.
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Dermal Laboratories Limited
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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
- •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.
Investigators
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