Trial · NCT03405818

An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents

NCT03405818, Phase 4, Completed, Pfizer; results first posted 2018-04-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents. Trials, record NCT03405818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03405818

On this page

Trial

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

Title: An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
NCT number: NCT03405818
Status: Completed
Phases: Phase 4
Enrollment: 55 participants, actual
Lead sponsor: Pfizer
Conditions: Onychomycosis, Tinea Unguium
Interventions: Tavaborole 5% Topical Solution
First posted: 2018-01-23
Last updated: 2018-04-17
Results first posted: 2018-04-17

Source ClinicalTrials.gov

Registered outcomes38

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Local Tolerability Reactions by Severity	Baseline up to Week 52	Local tolerability reactions consisted of burning/stinging, induration/edema, oozing and crusting, pruritus, erythema, and scaling. Here 0 indicates None, 1 (Mild), 2 (Moderate) and 3 (severe). Grading details are as follows: Burning/Stinging (0: no stinging/burning, 1: slight warm, 2: definite warm, 3: hot); Induration/Edema (0: no elevation, 1: barely perceptible elevation, 2: clearly perceptible elevation but not extensive, 3: marked and extensive elevation); Oozing and Crusting (0: absent, 1: faint signs of oozing, 2: definite oozing, 3: marked and extensive oozing); Pruritus (0: no pruritus, 1: occasional, slight itching, 2: constant itching which is not disturbing sleep, 3: severe bothersome itching/scratching which is disturbing sleep); Erythema (0: no redness present, 1: faintly detectable erythema; very light pink, 2: dull red, 3: deep/dark red); Scaling (0: no scaling, 1: barely perceptible shedding, 2: obvious but not profuse scaling, 3: heavy scale production).
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Baseline up to 28 days after last dose of study drug (up to Week 52)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs.
Primary	Number of Participants With Adverse Events (AEs) By Severity	Baseline up to 28 days after last dose of study drug (up to Week 52)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment by investigator and defined as: Mild = symptoms barely noticeable to the participant or does not make the participant uncomfortable; moderate = symptoms of a sufficient severity to make the participant uncomfortable; severe = symptoms of a sufficient severity to cause the participant severe discomfort.
Primary	Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24	Baseline, Week 24
Primary	Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52	Baseline, Week 52
Primary	Change From Baseline in Hematology Parameter (Hematocrit) at Week 24	Baseline, Week 24
Primary	Change From Baseline in Hematology Parameter (Hematocrit) at Week 52	Baseline, Week 52
Primary	Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24	Baseline, Week 24
Primary	Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52	Baseline, Week 52
Primary	Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24	Baseline, Week 24

1 to 10 of 38Source ClinicalTrials.gov

See all 38 registered outcomes

Outcomes38

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Local Tolerability Reactions by Severity	Baseline up to Week 52	Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Baseline up to 28 days after last dose of study drug (up to Week 52)	Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Adverse Events (AEs) By Severity	Baseline up to 28 days after last dose of study drug (up to Week 52)	Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24	Baseline, Week 24	Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.	percentage of leukocytes	MEAN
PRIMARY	Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52	Baseline, Week 52	Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.	percentage of leukocytes	MEAN
PRIMARY	Change From Baseline in Hematology Parameter (Hematocrit) at Week 24	Baseline, Week 24	Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.	volume percentage of red blood cells	MEAN
PRIMARY	Change From Baseline in Hematology Parameter (Hematocrit) at Week 52	Baseline, Week 52	Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.	volume percentage of red blood cells	MEAN
PRIMARY	Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24	Baseline, Week 24	Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.	10^12 cells per liter	MEAN
PRIMARY	Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52	Baseline, Week 52	Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.	10^12 cells per liter	MEAN
PRIMARY	Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24	Baseline, Week 24	Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.	gram per deciliter (g/dL)	MEAN

1 to 10 of 38Source ClinicalTrials.gov

See all 38 outcomes

Results by group119

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

Outcome	Group	Category	Value	Units
Number of Participants With Local Tolerability Reactions by Severity	Kerydin	None Burning/Stinging	54	Participants
Number of Participants With Local Tolerability Reactions by Severity	Kerydin	Mild Burning/Stinging	0	Participants
Number of Participants With Local Tolerability Reactions by Severity	Kerydin	Moderate Burning/Stinging	1	Participants
Number of Participants With Local Tolerability Reactions by Severity	Kerydin	Severe Burning/Stinging	0	Participants
Number of Participants With Local Tolerability Reactions by Severity	Kerydin	None Induration/Edema	53	Participants
Number of Participants With Local Tolerability Reactions by Severity	Kerydin	Mild Induration/Edema	4	Participants
Number of Participants With Local Tolerability Reactions by Severity	Kerydin	Moderate Induration/Edema	2	Participants
Number of Participants With Local Tolerability Reactions by Severity	Kerydin	Severe Induration/Edema	1	Participants
Number of Participants With Local Tolerability Reactions by Severity	Kerydin	None Oozing and Crusting	54	Participants
Number of Participants With Local Tolerability Reactions by Severity	Kerydin	Mild Oozing and Crusting	2	Participants

1 to 10 of 119Source ClinicalTrials.gov

See all 119 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Kerydin	55
Overall Study	COMPLETED	Kerydin	47
Overall Study	NOT COMPLETED	Kerydin	8

Source ClinicalTrials.gov

Adverse events44

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
other	Nasopharyngitis	Infections and infestations	Kerydin	7	54
other	Sinusitis	Infections and infestations	Kerydin	3	54
other	Influenza	Infections and infestations	Kerydin	2	54
other	Acute sinusitis	Infections and infestations	Kerydin	1	54
other	Conjunctivitis	Infections and infestations	Kerydin	1	54
other	Hand-foot-and-mouth disease	Infections and infestations	Kerydin	1	54
other	Paronychia	Infections and infestations	Kerydin	1	54
other	Pharyngitis	Infections and infestations	Kerydin	1	54
other	Pilonidal cyst	Infections and infestations	Kerydin	1	54
other	Respiratory tract infection	Infections and infestations	Kerydin	1	54

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Kerydin	0	54
Total, other adverse events	Kerydin	30	54
Total, serious adverse events	Kerydin	1	54

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30811142	DERIVED

Source PubMed

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03405818

GET https://conductscience.org/api/trials/v1/NCT03405818/registered?page=2

API reference For AI assistants