An emollient gel for the treatment of atopic dermatitis.

Phase 1

• Conditions: Atopic dermatitis.; MedDRA version: 14.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2010-023439-41-GB
• Lead Sponsor: Dermal Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-02
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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

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).

Study & Design

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