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Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1% (OPEN)

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ClinicalTrials.gov Identifier: NCT02705664
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma

Brief Summary:
The main objective of this study is to compare subject adherence and satisfaction for two modes of treatment toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and a Fungal Nail Treatment Set containing Urea 40% ointment (Urea) and Bifonazole cream 1% (Bifonazole).

Condition or disease Intervention/treatment Phase
Foot Dermatoses Drug: Loceryl Nail Lacquer Drug: Urea Ointment Drug: Bifonazole Cream Phase 4

Detailed Description:

A total of 20 subjects are to be included in 1 site in Iceland

Methodology:

Subjects will receive following treatments on the right or left toenails:

  • Loceryl Nail Lacquer (Loceryl NL) to be applied once weekly for 7 weeks on all affected toenails of one foot (including great toenail)
  • Fungal Nail Treatment Set to be used on all affected toenails (including great toenail) of the opposite foot in two phases:

    • Phase I: Urea ointment (Urea) to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal
    • Phase II: Bifonazole cream to (Bifonazole) be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus a Fungal Nail Treatment Set Containing Urea 40% Ointment and Bifonazole Cream 1%
Study Start Date : January 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 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 7 weeks on all affected toenails of one foot
Drug: Loceryl Nail Lacquer
Topical over entire toenail plates of affected toenails once weekly in the evening (at bed time) after having filled down affected toenails to gently remove as much as affected nails and having cleaned toenails surfaces with the provided cleansing swab
Other Name: Loceryl NL

Active Comparator: Urea Ointment + Bifonazole Cream

On the opposite foot:

  1. Urea 40% ointment to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal)
  2. Bifonazole 1% cream to be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment)
Drug: Urea Ointment
Topical over the infected part of the toenails only once daily under occlusion in the evening (at bed time) after having soaked toenails in warm water and having removed the soften infected toenail plates and dried the toenails
Other Name: Urea

Drug: Bifonazole Cream
Topical, to be rubbed sparingly over the affected toenail skin (nail bed) once daily in the evening (at bed time) after having cleaned and dried thoroughly toenails
Other Name: Bifonazole




Primary Outcome Measures :
  1. % adherent subjects with applications [ Time Frame: Week 7 ]
    Percent of subjects having applied both study treatments as instructed (once a week for Loceryl NL, once a day for urea and once a day for Bifonazole)

  2. % adherent subjects with nail preparation [ Time Frame: Week 7 ]

    Percent of subjects having prepared affected toenails as instructed for each product before applications:

    • For Loceryl: File down the affected toenails as required and clean toenails surface with the cleansing swab
    • For Urea: Soak toenails in warm water and remove soften infected toenails plates
    • For Bifonazole: Clean and dry thoroughly affected toenails

  3. % Subjects satisfied to very satisfied with each study treatment at week 7 [ Time Frame: Week 7 ]
    Percent of subjects satisfied to very satisfied with each study treatment at week 7



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

Inclusion Criteria:

  • Subjects with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one great toenail of each foot at screening visit,
  • Subjects with less than 50% of the toenail surface area from the Distal edge with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm,
  • Subjects should have the same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet,
  • Subjects with positive mycological results (direct microscopy and culture) of the most affected toenail (or great toenail) for dermatophytes or yeast (including Candida) at Baseline

Exclusion Criteria:

  • Subjects with matrix involvement on the great toenails,
  • Subjects with a surgical, medical condition or clinically important abnormal physical findings which might interfere with the interpretation of the objectives of the study
  • Post-traumatic toenail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance with the investigational products or mask the effects of treatment (cure),
  • 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): NCT02705664


Locations
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Iceland
Principal Investigator
Reykjavik, Iceland
Sponsors and Collaborators
Galderma
Investigators
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Principal Investigator: Dr Sigurgeirsson Cutis Ehf (Dermatology Center)

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Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT02705664     History of Changes
Other Study ID Numbers: RD.03.SPR.105078
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016

Keywords provided by Galderma:
Onychomycosis

Additional relevant MeSH terms:
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Onychomycosis
Skin Diseases
Foot Dermatoses
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Foot Diseases
Amorolfine
Bifonazole
Antifungal Agents
Anti-Infective Agents