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

Subacute local tolerance of an ointment containing 0.5% neomycin sulfate (Myacyne Salbe) - SLT of Myacyne ointment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-002284-14-DE
Enrollment
Unknown
Registered
2011-11-22
Start date
2012-03-14
Completion date
Unknown
Last updated
2012-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensitive skin areas under non-occlusive and occlusive conditions

Interventions

Trade Name: Myacyne Salbe Pharmaceutical Form: Ointment INN or Proposed INN: Neomycin sulfate CAS Number: 1406-04-3 Current Sponsor code: Not applicable Other descriptive name: Not applicable Concentr

Sponsors

Schur Pharmazeutika GmbH & Co. KG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: Testing of local tolerance;Secondary Objective: None;Primary end point(s): Use test: clinical scores for erythema, oedema/infitration, oozing/crusts, scaling, etat craquelé, pruritus, burning, tension, phototoxic and photosensitizing effects, transepidermal water loss patch test: 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

MeasureTime frame
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—

Countries

Germany

Contacts

Public ContactDr. Schalla

DPZ

schalla@derma.de+49761383068

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026