Trial Outcomes & Findings for Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser (NCT NCT01666002)
NCT ID: NCT01666002
Last Updated: 2016-05-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
1 year
Results posted on
2016-05-30
Participant Flow
We enrolled adults (18-75 years) with a clinical diagnosis of onychomycosis from the dermatology clinic at Stanford between July and December 2011. The key inclusion criterion was a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture.
Patients were randomized following simple randomization procedures (computerized random number generator) in a 2:1 ratio into laser or control groups.
Participant milestones
| Measure |
Treatment
1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
42 patients were assessed and 27 met eligibility criteria of a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture.
|
Placebo
1. st visit: For the control group, no treatment will be given.
2. nd visit: 2 weeks after initial visit, patient will be seen for second visit
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
10
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Treatment
1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
42 patients were assessed and 27 met eligibility criteria of a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture.
|
Placebo
1. st visit: For the control group, no treatment will be given.
2. nd visit: 2 weeks after initial visit, patient will be seen for second visit
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
Baseline Characteristics
Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
Baseline characteristics by cohort
| Measure |
Treatment
n=17 Participants
1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
|
Placebo
n=10 Participants
1. st visit: For the control group, no treatment will be given.
2. nd visit: 2 weeks after initial visit, patient will be seen for second visit
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 14 • n=5 Participants
|
65 years
STANDARD_DEVIATION 8 • n=7 Participants
|
59 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
10 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Treatment
n=12 Participants
1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
After 3 months, 4 of 12 patients (33%) in the laser group had negative fungal cultures. Of the 4 patients in the laser group with baseline cultures positive for a non-dermatophyte mold, 2 (50%) had negative fungal cultures. After 3 months of observation, 2 of 10 (20%) control subjects had negative cultures. Of the 3 patients in the control group with baseline cultures positive for a non-dermatophyte mold, 1 (33%) had a negative fungal culture. There was no significant difference in the percentage of patients with negative nail cultures between laser versus control groups (P = .49).
|
Placebo
n=10 Participants
1. st visit: For the control group, no treatment will be given.
2. nd visit: 2 weeks after initial visit, patient will be seen for second visit
|
|---|---|---|
|
The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.
|
12 percentage of participants
|
10 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearThe secondary end point was proximal nail plate clearance as assessed directly by a single study physician, who measured the clinical involvement defined as total length of abnormal nail per each nail of each of the patients' toenails, and confirmed by digital analysis of toenail photographs with ImageJ software.
Outcome measures
| Measure |
Treatment
n=39 nails
1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
After 3 months, 4 of 12 patients (33%) in the laser group had negative fungal cultures. Of the 4 patients in the laser group with baseline cultures positive for a non-dermatophyte mold, 2 (50%) had negative fungal cultures. After 3 months of observation, 2 of 10 (20%) control subjects had negative cultures. Of the 3 patients in the control group with baseline cultures positive for a non-dermatophyte mold, 1 (33%) had a negative fungal culture. There was no significant difference in the percentage of patients with negative nail cultures between laser versus control groups (P = .49).
|
Placebo
n=39 nails
1. st visit: For the control group, no treatment will be given.
2. nd visit: 2 weeks after initial visit, patient will be seen for second visit
|
|---|---|---|
|
Proximal Clearance of Fungus on Nail
|
0.44 mm
Standard Deviation 1.1
|
0.15 mm
Standard Deviation 0.7
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jean Tang MD PhD, assistant professor
Stanford University
Phone: 650-723-6316
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place