Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of a Leave-in Spray in Subjects With Head Lice Infestation (NCT NCT05565820)
NCT ID: NCT05565820
Last Updated: 2025-02-24
Results Overview
The total numbers of subjects in each group free of live lice at Days 2, 7, and 14, where 'live lice free" is defined as no presence of live adult or nymph lice. Zero subjects in each group were free of live lice at baseline. Since the two groups differed substantially in size, the numbers of live lice free subjects in each group at Days 2, 7, and 14 were transformed for analytical purposes to proportions of the respective group's participant totals on the respective days in order to achieve a metric that reflects commensurate degrees of difference between the two groups.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
58 participants
Primary outcome timeframe
2, 7, and 14 days from baseline
Results posted on
2025-02-24
Participant Flow
Participant milestones
| Measure |
Vamousse Spray 'n' Go
1. Recruitment Details:
Upon arrival at the clinic, lice-infested patients and their household members were screened for eligibility against the inclusion and exclusion criteria. Those in each household who passed the screening were assigned to one of the two treatment groups through a reversing alternation assignment procedure.
2. Type of Units Assigned:
Vamousse Spray 'n' Go Treatment Group: members of this group were treated at baseline and, if live lice were found, again at Day 7 subsequent to baseline with the Vamousse Spray 'n' Go product, which is a pediculicide for topical application, having as its active ingredient Natrum Muriaticum 2X (HPUS).
3. Periods:
A. Baseline to Day 7 Assessment 1) Completed 41 of the 43 subjects in this group completed this period. 2) Not Completed 2 subjects in this group dropped out of the study prior to the Day 7 assessment. B. Baseline to Day 14 Assessment 1) Completed 41 of the original 43 subjects in this group completed this period. 2) Not Completed 2 subjects in this group dropped out of the study prior to the 14th day after baseline.
4. Reasons Not Completed A. Reason Not Completed Type 1) Subject #16: Withdrawal by subject 2) Subject #17: Withdrawal by subject B. Reason Not Completed Data Withdrawal by subject: N = 2
|
Nix Creme Rinse Lice Treatment
1. Recruitment Details:
Upon arrival at the clinic, lice-infested patients and their household members were screened for eligibility against the inclusion and exclusion criteria. Those in each household who passed the screening were assigned to one of the two treatment groups through a reversing alternation assignment procedure.
2. Type of Units Assigned:
Nix Creme Rinse Lice Treatment Group: members of this group were treated at baseline and, if live lice were found, again at Day 7 subsequent to baseline with the Nix Creme Rinse Lice Treatment product, which is a pediculicide topical application having as its active ingredient permethrin at 1% concentration.
3. Periods:
A. Baseline to Day 7 Assessment 1) Completed 15 of the 15 subjects in this group completed this period. 2) Not Completed No subjects in this group dropped out of the study prior to the Day 7 assessment. B. Baseline to Day 14 Assessment 1) Completed 15 of the original 15 subjects in this group completed this period. 2) Not Completed No subjects in this group dropped out of the study prior to the 14th day after baseline.
4. Reasons Not Completed No subjects in this treatment group failed to complete the study.
|
|---|---|---|
|
2 Day Treatment Effectiveness
STARTED
|
43
|
15
|
|
2 Day Treatment Effectiveness
COMPLETED
|
43
|
15
|
|
2 Day Treatment Effectiveness
NOT COMPLETED
|
0
|
0
|
|
7 Day Treatment Effectiveness
STARTED
|
43
|
15
|
|
7 Day Treatment Effectiveness
COMPLETED
|
41
|
15
|
|
7 Day Treatment Effectiveness
NOT COMPLETED
|
2
|
0
|
|
14 Day Treatment Effectiveness
STARTED
|
43
|
15
|
|
14 Day Treatment Effectiveness
COMPLETED
|
41
|
15
|
|
14 Day Treatment Effectiveness
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Vamousse Spray 'n' Go
1. Recruitment Details:
Upon arrival at the clinic, lice-infested patients and their household members were screened for eligibility against the inclusion and exclusion criteria. Those in each household who passed the screening were assigned to one of the two treatment groups through a reversing alternation assignment procedure.
2. Type of Units Assigned:
Vamousse Spray 'n' Go Treatment Group: members of this group were treated at baseline and, if live lice were found, again at Day 7 subsequent to baseline with the Vamousse Spray 'n' Go product, which is a pediculicide for topical application, having as its active ingredient Natrum Muriaticum 2X (HPUS).
3. Periods:
A. Baseline to Day 7 Assessment 1) Completed 41 of the 43 subjects in this group completed this period. 2) Not Completed 2 subjects in this group dropped out of the study prior to the Day 7 assessment. B. Baseline to Day 14 Assessment 1) Completed 41 of the original 43 subjects in this group completed this period. 2) Not Completed 2 subjects in this group dropped out of the study prior to the 14th day after baseline.
4. Reasons Not Completed A. Reason Not Completed Type 1) Subject #16: Withdrawal by subject 2) Subject #17: Withdrawal by subject B. Reason Not Completed Data Withdrawal by subject: N = 2
|
Nix Creme Rinse Lice Treatment
1. Recruitment Details:
Upon arrival at the clinic, lice-infested patients and their household members were screened for eligibility against the inclusion and exclusion criteria. Those in each household who passed the screening were assigned to one of the two treatment groups through a reversing alternation assignment procedure.
2. Type of Units Assigned:
Nix Creme Rinse Lice Treatment Group: members of this group were treated at baseline and, if live lice were found, again at Day 7 subsequent to baseline with the Nix Creme Rinse Lice Treatment product, which is a pediculicide topical application having as its active ingredient permethrin at 1% concentration.
3. Periods:
A. Baseline to Day 7 Assessment 1) Completed 15 of the 15 subjects in this group completed this period. 2) Not Completed No subjects in this group dropped out of the study prior to the Day 7 assessment. B. Baseline to Day 14 Assessment 1) Completed 15 of the original 15 subjects in this group completed this period. 2) Not Completed No subjects in this group dropped out of the study prior to the 14th day after baseline.
4. Reasons Not Completed No subjects in this treatment group failed to complete the study.
|
|---|---|---|
|
7 Day Treatment Effectiveness
Withdrawal by Subject
|
2
|
0
|
|
14 Day Treatment Effectiveness
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of a Leave-in Spray in Subjects With Head Lice Infestation
Baseline characteristics by cohort
| Measure |
Vamousse Spray 'n' Go
n=43 Participants
The Vamousse Spray 'n' Go group is defined as the group of lice infected subjects who were treated with the Vamousse Spray 'n' Go product at baseline and if needed, on Day 7 following baseline. Treatment with this product consisted of fully coating the hair and scalp with the product, leaving it on for 8 hours and then shampooing at home by the subject with the subject's usual shampoo, and rinsed off with warm water followed by combing.
|
Nix Creme Rinse Lice Treatment
n=15 Participants
The Nix Creme Rinse Lice Treatment group is defined as the group of lice infected subjects who were treated with the Nix Creme Rinse Lice Treatment at baseline and if needed, on Day 7 following baseline. Treatment with this product consisted of the clinical staff first shampooing the subject's hair and scalp using regular shampoo and then thoroughly rinsing and towel drying the person's hair and scalp. After allowing the hair to air dry for a few minutes, they then thoroughly wet the subject's hair and scalp with the Nix Creme Rinse Lice Treatment lotion, being sure to cover the areas behind the ears and on the back of the neck.The lotion was allowed to remain in place for 10 minutes, after which the hair and scalp were thoroughly rinsed and dried with a clean towel.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
18.72 years
STANDARD_DEVIATION 14.27 • n=5 Participants
|
13.93 years
STANDARD_DEVIATION 13.87 • n=7 Participants
|
17.48 years
STANDARD_DEVIATION 14.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Hispanic
|
43 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Count of live lice
|
1270 live lice
n=5 Participants
|
288 live lice
n=7 Participants
|
1558 live lice
n=5 Participants
|
PRIMARY outcome
Timeframe: 2, 7, and 14 days from baselinePopulation: The 58 subjects who completed one or more of the three post-baseline assessments.
The total numbers of subjects in each group free of live lice at Days 2, 7, and 14, where 'live lice free" is defined as no presence of live adult or nymph lice. Zero subjects in each group were free of live lice at baseline. Since the two groups differed substantially in size, the numbers of live lice free subjects in each group at Days 2, 7, and 14 were transformed for analytical purposes to proportions of the respective group's participant totals on the respective days in order to achieve a metric that reflects commensurate degrees of difference between the two groups.
Outcome measures
| Measure |
Vamousse Spray 'n' Go
n=43 Participants
The Vamousse Spray 'n' Go group is defined as the group of lice infected subjects who were treated with the Vamousse Spray 'n' Go product at baseline and if needed, on Day 7 following baseline. Treatment with this product consisted of fully coating the hair and scalp with the product, leaving it on for 8 hours and then shampooing at home by the subject with the subject's usual shampoo, and rinsed off with warm water followed by combing.
|
Nix Creme Rinse Lice Treatment
n=15 Participants
The Nix Creme Rinse Lice Treatment group is defined as the group of lice infected subjects who were treated with the Nix Creme Rinse Lice Treatment at baseline and if needed, on Day 7 following baseline. Treatment with this product consisted of the clinical staff first shampooing the subject's hair and scalp using regular shampoo and then thoroughly rinsing and towel drying the person's hair and scalp. After allowing the hair to air dry for a few minutes, they then thoroughly wet the subject's hair and scalp with the Nix Creme Rinse Lice Treatment lotion, being sure to cover the areas behind the ears and on the back of the neck.The lotion was allowed to remain in place for 10 minutes, after which the hair and scalp were thoroughly rinsed and dried with a clean towel.
|
|---|---|---|
|
Proportion of Participants Who Are Completely Free of Live Lice
Baseline proportion
|
0.00 proportion of subjects free of live lice
|
0.00 proportion of subjects free of live lice
|
|
Proportion of Participants Who Are Completely Free of Live Lice
Day 2 proportion
|
.535 proportion of subjects free of live lice
|
.200 proportion of subjects free of live lice
|
|
Proportion of Participants Who Are Completely Free of Live Lice
Day 7 proportion
|
.415 proportion of subjects free of live lice
|
.067 proportion of subjects free of live lice
|
|
Proportion of Participants Who Are Completely Free of Live Lice
Day 14 proportion
|
.683 proportion of subjects free of live lice
|
.400 proportion of subjects free of live lice
|
SECONDARY outcome
Timeframe: 2, 7, and 14 days from baselinePopulation: All subjects who had completed one or more of the three assessments during the 14 day post-baseline portion of the study.
The counts of live lice at Days 2, 7, and 14 for were subtracted from the respective each participant's baseline count for the respective day. The resulting raw differences were transformed for analytical purposes to proportions of the respective participant's baseline live lice count in order to achieve a metric that reflected commensurate degrees of change, the means of which could be compared between the two groups for each interval from baseline. All proportions of change from baseline are negatively signed to reflect a reduction in the count from baseline, which occurred for both groups on all 3 post-baseline assessment days.
Outcome measures
| Measure |
Vamousse Spray 'n' Go
n=43 Participants
The Vamousse Spray 'n' Go group is defined as the group of lice infected subjects who were treated with the Vamousse Spray 'n' Go product at baseline and if needed, on Day 7 following baseline. Treatment with this product consisted of fully coating the hair and scalp with the product, leaving it on for 8 hours and then shampooing at home by the subject with the subject's usual shampoo, and rinsed off with warm water followed by combing.
|
Nix Creme Rinse Lice Treatment
n=15 Participants
The Nix Creme Rinse Lice Treatment group is defined as the group of lice infected subjects who were treated with the Nix Creme Rinse Lice Treatment at baseline and if needed, on Day 7 following baseline. Treatment with this product consisted of the clinical staff first shampooing the subject's hair and scalp using regular shampoo and then thoroughly rinsing and towel drying the person's hair and scalp. After allowing the hair to air dry for a few minutes, they then thoroughly wet the subject's hair and scalp with the Nix Creme Rinse Lice Treatment lotion, being sure to cover the areas behind the ears and on the back of the neck.The lotion was allowed to remain in place for 10 minutes, after which the hair and scalp were thoroughly rinsed and dried with a clean towel.
|
|---|---|---|
|
Proportion of Change in Total Number of Live Adult Lice and Nymphs From the Baseline
Day 2 proportion of change from baseline
|
-.859 proportion of change in number live lice
Standard Deviation .225
|
-.564 proportion of change in number live lice
Standard Deviation .424
|
|
Proportion of Change in Total Number of Live Adult Lice and Nymphs From the Baseline
Day 7 proportion of change from baseline
|
-.762 proportion of change in number live lice
Standard Deviation .666
|
-.549 proportion of change in number live lice
Standard Deviation .370
|
|
Proportion of Change in Total Number of Live Adult Lice and Nymphs From the Baseline
Day 14 proportion of change from baseline
|
-.926 proportion of change in number live lice
Standard Deviation .177
|
-.691 proportion of change in number live lice
Standard Deviation .386
|
Adverse Events
Vamousse Spray 'n' Go
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nix Creme Rinse Lice Treatment
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60