local tolerance of an ointment containing 0.5% neomycin sulfate (Myacyne Salbe) after daily topical application for 2 weeks

Conditions: Sensitive skin areas under non-occlusive and occlusive conditions
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2011-002284-14-DE

Lead Sponsor: Schur Pharmazeutika GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Healthy adults of either gender, at least 25% having a history of atopic diseases
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 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

Known hypersensitivity against any of the ingredients of the products; major health trouble; pregnant or lactating women or inadequate contraception; aged <18 years; participation in another CT within the last 30 days.
Additionally, in the period starting one week before treatment up to the end, not permitted are: treatment with other aminoglycoside antibiotics or neurotoxic substances; glucocorticoids and other immunotherapeutics as well as irritant or vasoactive compounds topically within the test region or systemically; massage within the test region

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Testing of local tolerance;Secondary Objective: None;Primary end point(s): Use test: <br>clinical scores for erythema, oedema/infitration, oozing/crusts, scaling, etat craquelé, pruritus, burning, tension, phototoxic and photosensitizing effects, transepidermal water loss<br>patch test: <br>clinical scores for erythema, oedema/infitration, oozing/crusts, discolouration/wrinkling, transepidermal water loss;Timepoint(s) of evaluation of this end point: Before first application (D1), D3, D5; D8, D10, D12; D15

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): There is no splitting into primary and secondary endpoints in ths tolerance study;Timepoint(s) of evaluation of this end point: Not applicable