Trial Outcomes & Findings for Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail (NCT NCT01278394)

NCT ID: NCT01278394

Last Updated: 2018-12-06

Results Overview

Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: Day 360
• Results posted on: 2018-12-06

Participant Flow

Subjects were screened and enrolled and two investigative sites in Mexico. The study population included men and women of any race, 18-65 years of age who had distal, subungual onychomycosis of the great toenail. The first subject visit occurred on March 28, 2007, and the last subject visit occurred on July 11, 2008.

All subjects in Cohort 3 were treated with 5.0% AN2690 Solution.

Participant milestones

Measure	AN2690 Solution, 5.0% AN2690 Solution, 5.0%: Once daily application for 360 days
Overall Study STARTED	29
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	AN2690 Solution, 5.0% AN2690 Solution, 5.0%: Once daily application for 360 days
Overall Study Lost to Follow-up	1

Baseline Characteristics

Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

Baseline characteristics by cohort

Measure	AN2690 Solution, 5.0% n=29 Participants AN2690 Solution, 5.0%: Once daily application for 360 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Mexico	29 participants n=5 Participants
Age	46.9 years STANDARD_DEVIATION 10.15 • n=5 Participants

PRIMARY outcome

Timeframe: Day 360

Population: Efficacy data were analyzed for the ITT population. For efficacy variables, the last observation was carried forward (LOCF) to impute missing observations.

Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.

Outcome measures

Measure	AN2690 Solution, 5.0% n=29 Participants AN2690 Solution, 5.0%: Once daily application for 360 days
Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360 Failure	27 participants
Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360 Success	2 participants Interval 0.0 to 16.1

SECONDARY outcome

Timeframe: Day 360

Population: Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.

Clear nail was measured on digital images as the distance in millimeters from the proximal nail fold to the proximal limit of the disease as marked by the Investigator. New Clear Nail Growth (CNG) was calculated from the clear nail measurements.

Outcome measures

Measure	AN2690 Solution, 5.0% n=29 Participants AN2690 Solution, 5.0%: Once daily application for 360 days
Clear Nail Growth of the Targeted Toenail	0.5 millimeters Interval -0.8 to 1.9

SECONDARY outcome

Timeframe: Day 90

Population: Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.

Number of subjects with negative KOH, and number of subjects with negative fungal cultures.

Outcome measures

Measure	AN2690 Solution, 5.0% n=29 Participants AN2690 Solution, 5.0%: Once daily application for 360 days
Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline Fungal Culture Result Positive	1 participants
Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline Fungal Culture Result Negative	28 participants Interval 89.9 to 100.0
Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline KOH Result Positive	24 participants
Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline KOH Result Negative	5 participants Interval 3.5 to 31.0

SECONDARY outcome

Timeframe: Day 180

Population: Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.

Number of subjects with negative KOH, and number of subjects with negative fungal cultures.

Outcome measures

Measure	AN2690 Solution, 5.0% n=29 Participants AN2690 Solution, 5.0%: Once daily application for 360 days
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline Fungal Culture Result Positive	0 participants
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline Fungal Culture Result Negative	29 participants Interval 100.0 to 100.0
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline KOH Result Positive	20 participants
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline KOH Result Negative	9 participants Interval 14.2 to 47.9

SECONDARY outcome

Timeframe: Day 270

Population: Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.

Number of subjects with negative KOH, and number of subjects with negative fungal cultures.

Outcome measures

Measure	AN2690 Solution, 5.0% n=29 Participants AN2690 Solution, 5.0%: Once daily application for 360 days
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline Fungal Culture Result Positive	1 participants
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline Fungal Culture Result Negative	28 participants Interval 89.9 to 100.0
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline KOH Result Positive	17 participants
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline KOH Result Negative	12 participants Interval 23.5 to 59.3

SECONDARY outcome

Timeframe: Day 360

Population: Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.

Number of subjects with negative KOH, and number of subjects with negative fungal cultures.

Outcome measures

Measure	AN2690 Solution, 5.0% n=29 Participants AN2690 Solution, 5.0%: Once daily application for 360 days
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline Fungal Culture Result Positive	1 participants
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline Fungal Culture Result Negative	28 participants Interval 89.9 to 100.0
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline KOH Result Positive	23 participants
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline KOH Result Negative	6 participants Interval 5.9 to 35.4

SECONDARY outcome

Timeframe: Baseline to 360

Population: Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.

Length of time to clinical evaluation of clear or at least 5 mm of CNG.

Outcome measures

Measure	AN2690 Solution, 5.0% n=29 Participants AN2690 Solution, 5.0%: Once daily application for 360 days
Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG	138.0 days Interval 81.5 to 194.0

Adverse Events

AN2690 Solution, 5.0%

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	AN2690 Solution, 5.0% n=29 participants at risk AN2690 Solution, 5.0%: Once daily application for 360 days
Reproductive system and breast disorders Uterine haemorrhage (unrelated)	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.

Other adverse events

Measure	AN2690 Solution, 5.0% n=29 participants at risk AN2690 Solution, 5.0%: Once daily application for 360 days
Blood and lymphatic system disorders Leukopenia	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Gastrointestinal disorders Gastritis	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
General disorders Pain	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Immune system disorders Drug hypersensitivity	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Infections and infestations Abscess	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Infections and infestations Gastroenteritis	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Infections and infestations Influenza	24.1% 7/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Infections and infestations Pyelonephritis	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Infections and infestations Tinea pedis	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Infections and infestations Tooth abscess	6.9% 2/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Infections and infestations Upper respiratory tract infection	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Infections and infestations Vaginal infection	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Injury, poisoning and procedural complications Limb injury	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Injury, poisoning and procedural complications Skin laceration	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Investigations Blood glucose abnormal	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Nervous system disorders Epilepsy	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Psychiatric disorders Depression	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Reproductive system and breast disorders Polycystic ovaries	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Skin and subcutaneous tissue disorders Ingrowing nail	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Skin and subcutaneous tissue disorders Onychomadesis	3.4% 1/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Surgical and medical procedures Tooth extraction	10.3% 3/29 • Pre and post treatment to Day 360 AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.

Additional Information

Sheryl Baldwin, RN/Associate Director

Anacor Pharmaceuticals, Inc.

Phone: 650-223-8597

Email: clinicaltrials@anacor.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institution or Principal Investigator may only publish Study results after: (i) the results of the multicenter Study in its entirety have been publicly disclosed by the Sponsor in an abstract, manuscript or presentation form, or (ii) two (2) years after conclusion of the Study at all sites, whichever is first to occur.
• Publication restrictions are in place

Restriction type: OTHER