Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer (LOOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679911
Recruitment Status : Completed
First Posted : February 11, 2016
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Galderma

Brief 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).

Condition or disease Intervention/treatment Phase
Foot Dermatoses Drug: Loceryl NL Drug: Ciclopirox NL Phase 4

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intra-individual study
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Loceryl NL
Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot
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.
Other Name: Loceryl Nail Lacquer

Active Comparator: Ciclopirox NL
Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot
Drug: 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
Other Name: Ciclopirox Nail Lacquer




Primary Outcome Measures :
  1. % "in Label" Adherent Subjects [ Time Frame: Week 12 ]
    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)


Secondary Outcome Measures :
  1. % Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12 [ Time Frame: Week 12 ]
    Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679911


Locations
Layout table for location information
Germany
Tübingen, Germany
Sponsors and Collaborators
Galderma
Investigators
Layout table for investigator information
Principal Investigator: Prof. Schaller Universitäts-Hautklinik

Layout table for additonal information
Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT02679911     History of Changes
Other Study ID Numbers: RD.03.SPR105082
2015-001237-24 ( EudraCT Number )
First Posted: February 11, 2016    Key Record Dates
Results First Posted: October 3, 2018
Last Update Posted: October 3, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Galderma:
Onychomycosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Onychomycosis
Skin Diseases
Foot Dermatoses
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Foot Diseases
Ciclopirox
Amorolfine
Antifungal Agents
Anti-Infective Agents