Trial · NCT01851590

Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis

NCT01851590, Phase 4, Completed, Helsinki University Central Hospital; results first posted 2015-11-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis. Trials, record NCT01851590. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01851590

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis
NCT number: NCT01851590
Status: Completed
Phases: Phase 4
Enrollment: 129 participants, actual
Lead sponsor: Helsinki University Central Hospital
Conditions: Onychomycosis
Interventions: Resin Lacquer, Amorolfine, Terbinafine
First posted: 2013-05-10
Last updated: 2015-11-30
Other registries' IDs: eudract:2012-004822-48
Results first posted: 2015-11-30
Limitations and caveats: * Relatively short treatment period for the toenail onychomycosis (9 months).~* Patients with total dystrophic onychomycosis (46%) - the most difficult subtype to treat - may not have been amenable to monotherapy with a topical antifungal treatment.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mycological Cure	At 4- and 10 months time-points from the beginning of the study.	To analyze the rate of complete mycological cure i.e. fungal eradication in terms of negative mycological culture AND negative potassium hydroxide (KOH) stain at 4- and 10 months time-points from the beginning of the study.
Secondary	Clinical Responses to the Treatments	At 4- and 10 months time-points from the beginning of the study.	Clinical responses to treatment were based on the proximal linear growth of healthy nail; thus, the clinical responses were classified as partial (evident proximal linear growth of healthy nail) or complete. Partial responses were defined as significant reductions in onycholysis, subungual hyperkeratosis, and streaks. A complete response was a fully normal appearance of the toenail.
Secondary	Cost-effectiveness 1	At 10-month time-point	Cost analysis was based on the retail price (€) and consumption of a 10 ml bottle of Abicin® 30% resin lacquer, a 5 ml bottle of Loceryl® 5% amorolfine lacquer, and 98 tablets of generic 250 mg terbinafine, sold by the University Pharmacy in Helsinki, Finland, January 2014. The cost was expressed as the average treatment cost per patient; for the total cost, this average was extrapolated to the entire study treatment arm. The results show the treatment costs (€) per day per patient in each group.
Secondary	Cost-effectiveness 2	At 10-month time-point	Cost analysis was based on the retail price (€) and consumption of a 10 ml bottle of Abicin® 30% resin lacquer, a 5 ml bottle of Loceryl® 5% amorolfine lacquer, and 98 tablets of generic 250 mg terbinafine, sold by the University Pharmacy in Helsinki, Finland, January 2014. The cost was expressed as the average treatment cost per patient; for the total cost, this average was extrapolated to the entire study treatment arm. The results show the treatment costs (€) during the treatment period per patient in each group.
Secondary	Compliance to the Treatment	At 4-month time-point	Evaluation of compliance was based on patient self-reports of whether the treatment protocol was followed 100% (complete), 80% (good), 60% (moderate), or 40% (poor) of the time.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mycological Cure	At 4- and 10 months time-points from the beginning of the study.	Primary and secondary outcome analyses were based on the intent-to-treat (ITT) population and missing values were imputed using the last observation carried forward (LOCF) method.	Percentage of participants	NUMBER
SECONDARY	Clinical Responses to the Treatments	At 4- and 10 months time-points from the beginning of the study.	Intention-to-treat population, last observation carried forward.	percentage of participants	NUMBER
SECONDARY	Cost-effectiveness 1	At 10-month time-point		Euros (€)	MEAN
SECONDARY	Cost-effectiveness 2	At 10-month time-point		Euros (€)	MEAN
SECONDARY	Compliance to the Treatment	At 4-month time-point	Percentage describes the proportion of patients who declared that they have been followed the instructions completely (100%).	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group27

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mycological Cure	Resin Lacquer Arm	Mycological cure at 4-month	17	95% Confidence Interval 1 to 34	Percentage of participants
Mycological Cure	Amorolfine Lacquer Arm	Mycological cure at 4-month	28	95% Confidence Interval 9 to 47	Percentage of participants
Mycological Cure	Terbinafine Arm	Mycological cure at 4-month	16	95% Confidence Interval 0 to 31	Percentage of participants
Mycological Cure	Resin Lacquer Arm	Mycological cure at 10-month	13	95% Confidence Interval 0 to 28	Percentage of participants
Mycological Cure	Amorolfine Lacquer Arm	Mycological cure at 10-month	8	95% Confidence Interval 0 to 19	Percentage of participants
Mycological Cure	Terbinafine Arm	Mycological cure at 10-month	56	95% Confidence Interval 35 to 77	Percentage of participants
Clinical Responses to the Treatments	Resin Lacquer Arm	Partial clinical response at 4-month	0		percentage of participants
Clinical Responses to the Treatments	Amorolfine Lacquer Arm	Partial clinical response at 4-month	0		percentage of participants
Clinical Responses to the Treatments	Terbinafine Arm	Partial clinical response at 4-month	44		percentage of participants
Clinical Responses to the Treatments	Resin Lacquer Arm	Complete clinical response at 4-month	0		percentage of participants

1 to 10 of 27Source ClinicalTrials.gov

See all 27 results by group

Participant flow21

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Resin Lacquer Arm	23
Overall Study	STARTED	Amorolfine Lacquer Arm	25
Overall Study	STARTED	Terbinafine Arm	25
Overall Study	At 3 Month: End of Terbinafine Treatment	Resin Lacquer Arm	23
Overall Study	At 3 Month: End of Terbinafine Treatment	Amorolfine Lacquer Arm	24
Overall Study	At 3 Month: End of Terbinafine Treatment	Terbinafine Arm	22
Overall Study	At 4 Month: Follow-up Visit and Control	Resin Lacquer Arm	23
Overall Study	At 4 Month: Follow-up Visit and Control	Amorolfine Lacquer Arm	24
Overall Study	At 4 Month: Follow-up Visit and Control	Terbinafine Arm	22
Overall Study	At 9 Month: End of Topical Treatments	Resin Lacquer Arm	23

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Resin Lacquer Arm	0	23	0
other	Diarrhoea	Gastrointestinal disorders	Amorolfine Lacquer Arm	0	25	0
other	Diarrhoea	Gastrointestinal disorders	Terbinafine Arm	1	25	1
other	Rash	Skin and subcutaneous tissue disorders	Resin Lacquer Arm	0	23	0
other	Rash	Skin and subcutaneous tissue disorders	Amorolfine Lacquer Arm	0	25	0
other	Rash	Skin and subcutaneous tissue disorders	Terbinafine Arm	1	25	1

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Resin Lacquer Arm
Total, all-cause mortality	Amorolfine Lacquer Arm
Total, all-cause mortality	Terbinafine Arm
Total, other adverse events	Resin Lacquer Arm	0	23
Total, other adverse events	Amorolfine Lacquer Arm	0	25
Total, other adverse events	Terbinafine Arm	2	25
Total, serious adverse events	Resin Lacquer Arm	0	23
Total, serious adverse events	Amorolfine Lacquer Arm	0	25
Total, serious adverse events	Terbinafine Arm	0	25

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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