Trial · NCT00730405

Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis

NCT00730405, Phase 2, Completed, Stiefel, a GSK Company; results first posted 2018-02-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis. Trials, record NCT00730405. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00730405

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Trial

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

Title: Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis
NCT number: NCT00730405
Status: Completed
Phases: Phase 2
Enrollment: 582 participants, actual
Lead sponsor: Stiefel, a GSK Company
Conditions: Onychomycosis
Interventions: Albaconazole 100mg, Albaconazole 200mg, Albaconazole 400mg, Albaconazole 400mg, Placebo 400 mg
First posted: 2008-08-08
Last updated: 2018-03-12
Results first posted: 2018-02-07

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	The Percentage of Participants Who Achieve Effective Treatment at Week 52	Week 52	At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Effective treatment was defined as a mycological cure and clear or almost clear nail (distal subungual hyperkeratosis and/or onycholysis leaving less than 10% of nail plate effected). Comparisons were carried out in a sequential step-down fashion, combined with the Holm procedure at step 2. P-value was based on a sequential step-down combined with the Holm procedure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Secondary	The Percentage of Participants Who Achieve Clinical Cure at Week 52	Week 52	At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Clinical cure was defined as 100% clear nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Secondary	The Percentage of Participants Who Achieve Mycological Cure at Week 52	Week 52	At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Mycological cure was defined as negative potassium hydroxide (KOH) and negative cultures for dermatophytes. It was assessed on Week 12, 16, 20, 24, 30, 36, 44 and 52.
Secondary	The Percentage of Participants Who Achieve Complete Cure at Week 52	Week 52	At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Complete cure was defined as mycological cure plus clinical cure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Secondary	Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52	Baseline (Week 0/Day 1 or before) and up to Week 52	Length of the unaffected part of the target nail was measured in millimeters along the midpoint from the nail fold to the proximal border of the affected part (lowest point affected) along the midpoint of the target nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52. Baseline values were the observations at Week 0/Day 1 or before. Change from Baseline was a Baseline value subtracted from Week 52 value. P-value was based on analysis of variance (ANOVA) with treatment and pooled center. Statistics is provided for adjusted least square mean.
Secondary	The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52	Week 52	A count of the number of toenails affected, using visual examination, was performed at all study visits (Week 12, 24, 30, 36, 44 and 52). The investigator given a global evaluation of the toenails condition, based on the investigator's assessment of the reduction in extent of nail involvement and improvement in clinical signs as compared with the status at the Baseline visit. The 0-5 rating scale was used: 0: cleared, 1: much improved, 2: minimally improved, 3: unchanged, 4: minimally worse and 5: much worse; where higher score indicates worse condition and lower score indicates clear toenail.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Percentage of Participants Who Achieve Effective Treatment at Week 52	Week 52	The intent-to-treat (ITT) analysis set consists of all randomized participants who receive study product. All participants were available at the time of assessment.	Percentage of participants	NUMBER
SECONDARY	The Percentage of Participants Who Achieve Clinical Cure at Week 52	Week 52	ITT analysis set. All participants were available at the time of assessment.	Percentage of participants	NUMBER
SECONDARY	The Percentage of Participants Who Achieve Mycological Cure at Week 52	Week 52	ITT analysis set. All participants were available at the time of assessment.	Percentage of participants	NUMBER
SECONDARY	The Percentage of Participants Who Achieve Complete Cure at Week 52	Week 52	ITT analysis set. All participants were available at the time of assessment.	Percentage of participants	NUMBER
SECONDARY	Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52	Baseline (Week 0/Day 1 or before) and up to Week 52	ITT analysis set. All participants were available at the time of assessment.	Millimeters	MEAN
SECONDARY	The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52	Week 52	ITT analysis set. All participants were available at the time of assessment.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group30

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

Outcome	Group	Value	Spread	Units
The Percentage of Participants Who Achieve Effective Treatment at Week 52	Albaconazole 400 mg (36 Weeks) Oral Weekly	54	95% Confidence Interval 45.2 to 63.4	Percentage of participants
The Percentage of Participants Who Achieve Effective Treatment at Week 52	Albaconazole 400 mg (24 Weeks) Oral Weekly	38	95% Confidence Interval 28.8 to 46.4	Percentage of participants
The Percentage of Participants Who Achieve Effective Treatment at Week 52	Albaconazole 200 mg (36 Weeks) Oral Weekly	29	95% Confidence Interval 20.8 to 37.3	Percentage of participants
The Percentage of Participants Who Achieve Effective Treatment at Week 52	Albaconazole 100 mg (36 Weeks) Oral Weekly	21	95% Confidence Interval 13.2 to 27.8	Percentage of participants
The Percentage of Participants Who Achieve Effective Treatment at Week 52	Placebo	1	95% Confidence Interval 0.0 to 2.6	Percentage of participants
The Percentage of Participants Who Achieve Clinical Cure at Week 52	Albaconazole 400 mg (36 Weeks) Oral Weekly	34	95% Confidence Interval 25.0 to 42.2	Percentage of participants
The Percentage of Participants Who Achieve Clinical Cure at Week 52	Albaconazole 400 mg (24 Weeks) Oral Weekly	32	95% Confidence Interval 23.2 to 40.0	Percentage of participants
The Percentage of Participants Who Achieve Clinical Cure at Week 52	Albaconazole 200 mg (36 Weeks) Oral Weekly	30	95% Confidence Interval 21.6 to 38.2	Percentage of participants
The Percentage of Participants Who Achieve Clinical Cure at Week 52	Albaconazole 100 mg (36 Weeks) Oral Weekly	16	95% Confidence Interval 9.6 to 22.9	Percentage of participants
The Percentage of Participants Who Achieve Clinical Cure at Week 52	Placebo	1	95% Confidence Interval 0.0 to 2.6	Percentage of participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow30

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

Period	Milestone	Group	Participants
Overall Study-Treatment Phase	STARTED	Albaconazole 400 mg (36 Weeks) Oral Weekly	116
Overall Study-Treatment Phase	STARTED	Albaconazole 400 mg (24 Weeks) Oral Weekly	117
Overall Study-Treatment Phase	STARTED	Albaconazole 200 mg (36 Weeks) Oral Weekly	117
Overall Study-Treatment Phase	STARTED	Albaconazole 100 mg (36 Weeks) Oral Weekly	117
Overall Study-Treatment Phase	STARTED	Placebo	115
Overall Study-Treatment Phase	COMPLETED	Albaconazole 400 mg (36 Weeks) Oral Weekly	97
Overall Study-Treatment Phase	COMPLETED	Albaconazole 400 mg (24 Weeks) Oral Weekly	96
Overall Study-Treatment Phase	COMPLETED	Albaconazole 200 mg (36 Weeks) Oral Weekly	96
Overall Study-Treatment Phase	COMPLETED	Albaconazole 100 mg (36 Weeks) Oral Weekly	98
Overall Study-Treatment Phase	COMPLETED	Placebo	95

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events125

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
serious	Coronary artery disease	Cardiac disorders	Albaconazole 400 mg (36 Weeks) Oral Weekly	0	116
serious	Coronary artery disease	Cardiac disorders	Albaconazole 400 mg (24 Weeks) Oral Weekly	1	117
serious	Coronary artery disease	Cardiac disorders	Albaconazole 200 mg (36 Weeks) Oral Weekly	0	117
serious	Coronary artery disease	Cardiac disorders	Albaconazole 100 mg (36 Weeks) Oral Weekly	0	117
serious	Coronary artery disease	Cardiac disorders	Placebo	0	115
serious	Cholecystitis	Hepatobiliary disorders	Albaconazole 400 mg (36 Weeks) Oral Weekly	0	116
serious	Cholecystitis	Hepatobiliary disorders	Albaconazole 400 mg (24 Weeks) Oral Weekly	0	117
serious	Cholecystitis	Hepatobiliary disorders	Albaconazole 200 mg (36 Weeks) Oral Weekly	1	117
serious	Cholecystitis	Hepatobiliary disorders	Albaconazole 100 mg (36 Weeks) Oral Weekly	0	117
serious	Cholecystitis	Hepatobiliary disorders	Placebo	0	115

1 to 10 of 125Source ClinicalTrials.gov

See all 125 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Albaconazole 400 mg (36 Weeks) Oral Weekly	0	116
Total, all-cause mortality	Albaconazole 400 mg (24 Weeks) Oral Weekly	1	117
Total, all-cause mortality	Albaconazole 200 mg (36 Weeks) Oral Weekly	0	117
Total, all-cause mortality	Albaconazole 100 mg (36 Weeks) Oral Weekly	1	117
Total, all-cause mortality	Placebo	0	115
Total, other adverse events	Albaconazole 400 mg (36 Weeks) Oral Weekly	0	0
Total, other adverse events	Albaconazole 400 mg (24 Weeks) Oral Weekly	0	0
Total, other adverse events	Albaconazole 200 mg (36 Weeks) Oral Weekly	0	0
Total, other adverse events	Albaconazole 100 mg (36 Weeks) Oral Weekly	0	0
Total, other adverse events	Placebo	0	0

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23706639	BACKGROUND

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/NCT00730405

GET https://conductscience.org/api/trials/v1/NCT00730405/results?page=2

API reference For AI assistants