Trial Outcomes & Findings for Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis (NCT NCT00143819)
NCT ID: NCT00143819
Last Updated: 2017-04-25
Results Overview
Subjects assessed the level of pruritus (itching) on the left and right sides of their body at each visit, ticking the values on a 100-mm scale (0 mm = no itching; 100 mm = worst possible itching) for each side. Percent change from baseline was calculated.
TERMINATED
PHASE2
13 participants
8 weeks
2017-04-25
Participant Flow
Participant milestones
| Measure |
1 (Left Side: Active; Right Side: Placebo)
bilateral comparison
Subjects randomized to Group 1 applied Neuroskin Forte study drug sprays to the left side of the body and placebo sprays to the right side of the body, 3 times a day (with optional 4th application), for 8 weeks.
|
2 (Left Side: Placebo; Right Side: Active)
bilateral comparison
Subjects randomized to Group 2 applied placebo sprays to the left side of the body and Neuroskin Forte study drug sprays to the right side of the body, 3 times a day (with optional 4th application), for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
8
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis
Baseline characteristics by cohort
| Measure |
Bilateral Comparison Group 1
n=5 Participants
bilateral comparison
Neuroskin Forte: Subjects will apply study drug sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks
|
Bilateral Comparison Group 2
n=8 Participants
bilateral comparison
Placebo Application: Subjects will apply placebo sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Continuous
|
66 years
n=99 Participants
|
61 years
n=107 Participants
|
63 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
8 participants
n=107 Participants
|
13 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.
Subjects assessed the level of pruritus (itching) on the left and right sides of their body at each visit, ticking the values on a 100-mm scale (0 mm = no itching; 100 mm = worst possible itching) for each side. Percent change from baseline was calculated.
Outcome measures
| Measure |
Neuroskin Forte Spray
n=13 Participants
bilateral comparison
Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks.
|
Placebo Spray
n=13 Participants
bilateral comparison
Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks.
|
|---|---|---|
|
Change From Baseline in the Visual Analog Scale (VAS) Score for Pruritus (Itching) at 8 Weeks
|
-52.2 percent change
Standard Deviation 34.6
|
-36.2 percent change
Standard Deviation 28.5
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The eight (8) subjects in the study who had psoriasis were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.
For subjects with psoriasis, a global assessment (scale of 0-5: 0 = clear except for residual discoloration; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 = severe) was performed and a score recorded for each side of the subject's body, at each visit.
Outcome measures
| Measure |
Neuroskin Forte Spray
n=8 Participants
bilateral comparison
Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks.
|
Placebo Spray
n=8 Participants
bilateral comparison
Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks.
|
|---|---|---|
|
Number of Participants With a Psoriasis ½-Body Physician Global Assessment (PGA) Improvement of at Least 2 Levels
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The five (5) subjects in the study who had eczema were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.
For subjects with eczema, a global assessment (scale of 0-5: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe; 5 = very severe) was performed and a score recorded for each side of the subject's body, at each visit.
Outcome measures
| Measure |
Neuroskin Forte Spray
n=5 Participants
bilateral comparison
Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks.
|
Placebo Spray
n=5 Participants
bilateral comparison
Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks.
|
|---|---|---|
|
Number of Participants With an Eczema ½-Body Investigator Global Assessment (IGA) Improvement of at Least 2 Levels
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.
The subjects' target lesions (ie, a pair of roughly symmetrical bilateral lesions) on each side of the body were scored by the investigator at each visit. Percent change from baseline was calculated.
Outcome measures
| Measure |
Neuroskin Forte Spray
n=13 Participants
bilateral comparison
Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks.
|
Placebo Spray
n=13 Participants
bilateral comparison
Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks.
|
|---|---|---|
|
Change in Target Lesion Scoring
|
-20.7 percent change
Standard Deviation 27.5
|
-14.7 percent change
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.
Number of participants with photographs taken
Outcome measures
| Measure |
Neuroskin Forte Spray
n=13 Participants
bilateral comparison
Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks.
|
Placebo Spray
n=13 Participants
bilateral comparison
Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks.
|
|---|---|---|
|
Photography of Target Lesions
|
13 Participants
|
13 Participants
|
Adverse Events
Bilateral Comparison: Neuroskin Forte Spray vs Placebo Spray
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bilateral Comparison: Neuroskin Forte Spray vs Placebo Spray
n=13 participants at risk
bilateral comparison
Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body and placebo spray to the other side of the body, 3 times a day (with optional 4th application), for 8 weeks.
|
|---|---|
|
Infections and infestations
skin infection
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
increased itching
|
15.4%
2/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
pneumonia
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
increased severity of eczema
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
upper respiratory infection
|
7.7%
1/13 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place