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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02679911
Other study ID # RD.03.SPR105082
Secondary ID 2015-001237-24
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2015
Est. completion date June 2016

Study information

Verified date February 2018
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of this study is to compare subject's compliance and satisfaction for two modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).


Description:

A total of 20 subjects are to be included in 1 site in Germany. Methodology: Subjects will receive the following treatments on the right or left toenails: - Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails of one foot. - Ciclopirox Nail Lacquer to be applied once daily for 12 weeks on all affected toenails of the opposite foot.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one toenail of each foot at screening visit, - Subject with less than 80% of the nail surface area with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm, - Subjects with positive mycological results (direct microscopy and culture) for dermatophytes and/or yeasts (including Candida) at baseline, - Subjects with same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet, Exclusion Criteria: - Subject with a surgical, medical condition or clinically important abnormal physical findings, which, in the judgement of the investigator, might interfere with interpretation of the objectives of the study (i.e. lack of autonomy), - Subjects with post-traumatic nail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance of the investigational products, or mask the effects of treatment (cure), - Subjects with known immunodeficiency, radiation therapy, immune suppressive drugs.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Loceryl NL
Topical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails.
Ciclopirox NL
Topical over the entire toenail plate of all affected toenails and surrounding skin, once daily in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of "in Label" Adherent Subjects Percent of subjects having applied both treatments as instructed per labeling (once a week for Loceryl NL and once a day for Ciclopirox after 2 weeks) Week 12
Secondary Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12 Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12 Week 12
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