Erbium-doped Yttrium Aluminium Garnet Laser(Er:Yag)Associated With Amorolfine Lacquer in the Treatment of Onychomycosis
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Purpose
The study aims to investigate the effectiveness of a single application of Er:YAG laser to the nail plate in increasing the efficacy of the amorolfine lacquer used in the treatment of onychomycosis (fungal infection of nails) cause by dermatophyte molds. This clinical trial respective involve 30 subjects with hands or feet distal-lateral subungual onychomycosis (a kind of onychomycosis that does not affect the ungual matrix). The patients will receive treatment for 6 months meanwhile they will be followed up to access efficacy of the treatment by means of the clearance of nail plate infection.
| Condition | Intervention | Phase |
|---|---|---|
|
Onychomycosis |
Device: Er:YAG laser + amorolfine lacquer Drug: Amorolfine lacquer |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | AVALIAÇÃO DO USO DO LASER ERBIUM-DOPED YTTRIUM ALUMINIUM GARNET (Er:YAG) ASSOCIADO AO ESMALTE DE AMOROLFINA NO TRATAMENTO DA ONICOMICOSE |
- Extent of nail plate damage [ Time Frame: 6 months ] [ Designated as safety issue: No ]At the beginning and after 6 months of treatment both the group, A and B, will have the length from nail cuticle to the closest point of damage to the nail plate measured by a millimeter scale. It will later be accessed to determine the clearance rate of the nail plate achieved with each treatment
- Mycological cure [ Time Frame: 6 months ] [ Designated as safety issue: No ]After 6 months of treatment both the group, A and B, will be accessed by direct mycological examination and culture to evaluate mycological cure
- Clinical cure [ Time Frame: 6 months ] [ Designated as safety issue: No ]After 6 months of treatment both the group, A and B, will be accessed by dermatological examination to evaluate clinical cure
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Er:YAG + amorolfine lacquer
30 ungual units affected by onychomycosis due to dermatophytes
|
Device: Er:YAG laser + amorolfine lacquer
To each compromised ungual unit randomly assigned to this group it will be applied a single session of Er:YAG laser to the ungual lamina in the beginning of study. Onwards, amorolfine lacquer will be applied weekly for a period of 06 months.
Other Names:
|
|
Placebo Comparator: Amorolfine lacquer
30 ungual units affected by onychomycosis due to dermatophytes
|
Drug: Amorolfine lacquer
To each compromised ungual unit randomly assigned to this group, it will be applied amorolfine lacquer weekly for a period of 06 months.
Other Name: Loceryl
|
Detailed Description:
This is a trial study involving 30 subjects with onychomycosis of hands or feet. The patient must have at least 2 injured nails as each affected nail will receive a different treatment - self-controlled study design.
Therefore, each nail out of two from a single patient will be randomized into the following study arms:
Group A of nails - will receive only weekly application of amorolfine lacquer for a total of 6 months.
Group B of nails - will receive a single application of Er:YAG laser followed by weekly application of amorolfine lacquer for a total of 6 months.
At the end of 6 months the data from both groups, A and B, regarding *clinical cure, *mycological cure and *extent of damage to the nail plates will be analyzed using specific tests.
Eligibility| Ages Eligible for Study: | 19 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 19-60 year-old
- preserved cognitive status
- direct mycological examination or culture showing infection of hands or feet nails by dermatophyte molds
Exclusion Criteria:
- diabetes type 1 or 2; peripheral vascular disease
- having undergone any treatment in the last 6 months
- peripheral nerve disorders (e.g. peripheral neuropathy, Hansen's disease, etc)
- willing to paint nail during the study
- high blood pressure
- use of any immunosuppressive drugs; congenital or acquired immunodeficiency
Contacts and Locations| Brazil | |
| University Hospital of Brasilia | |
| Brasilia, Federal District, Brazil, 70910-900 | |
| Study Director: | Izelda Maria C Costa, Ph.D. | University of Brasilia |
| Principal Investigator: | Orlando O Morais, M.D. | University of Brasilia |
More Information
No publications provided
| Responsible Party: | Izelda Maria Carvalho Costa, Adjunct Professor, Brasilia University Hospital |
| ClinicalTrials.gov Identifier: | NCT01528813 History of Changes |
| Other Study ID Numbers: | HUB-UnB OnychoLASER |
| Study First Received: | February 5, 2012 |
| Last Updated: | February 27, 2013 |
| Health Authority: | Brazil: Ethics Committee Brazil: National Committee of Ethics in Research |
Keywords provided by Brasilia University Hospital:
|
Erbium-doped yttrium aluminium garnet laser Er:YAG Amorolfine lacquer |
Dermatophytes Subungual distal lateral onychomycosis Drug delivery |
Additional relevant MeSH terms:
|
Onychomycosis Tinea Dermatomycoses Skin Diseases, Infectious Infection Mycoses Nail Diseases |
Skin Diseases Amorolfine Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013