Erbium-doped Yttrium Aluminium Garnet Laser(Er:Yag)Associated With Amorolfine Lacquer in the Treatment of Onychomycosis
![]() |
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: NCT01528813 |
Recruitment Status : Unknown
Verified August 2013 by Izelda Maria Carvalho Costa, Brasilia University Hospital.
Recruitment status was: Recruiting
First Posted : February 8, 2012
Last Update Posted : August 7, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Onychomycosis | Device: Er:YAG laser + amorolfine lacquer Drug: Amorolfine lacquer | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | February 2012 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
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 |
- Extent of nail plate damage [ Time Frame: 6 months ]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 ]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 ]After 6 months of treatment both the group, A and B, will be accessed by dermatological examination to evaluate clinical cure

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.
Ages Eligible for Study: | 19 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
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

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): NCT01528813
Contact: Orlando O Morais, Investigator | +55(61)9916-2339 | orlando.unb@gmail.com |
Brazil | |
University Hospital of Brasilia | Recruiting |
Brasilia, Federal District, Brazil, 70910-900 | |
Contact: Orlando O Morais, M.D. +55(61)99162339 orlando.unb@gmail.com | |
Principal Investigator: Orlando O Morais, M.D. |
Principal Investigator: | Orlando O Morais, M.D. | University of Brasilia |
Responsible Party: | Izelda Maria Carvalho Costa, Adjunct Professor, Brasilia University Hospital |
ClinicalTrials.gov Identifier: | NCT01528813 |
Other Study ID Numbers: |
HUB-UnB OnychoLASER |
First Posted: | February 8, 2012 Key Record Dates |
Last Update Posted: | August 7, 2013 |
Last Verified: | August 2013 |
Erbium-doped yttrium aluminium garnet laser Er:YAG Amorolfine lacquer |
Dermatophytes Subungual distal lateral onychomycosis Drug delivery |
Onychomycosis Tinea Dermatomycoses Skin Diseases, Infectious Infection Mycoses |
Nail Diseases Skin Diseases Amorolfine Antifungal Agents Anti-Infective Agents |