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Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis

This study has been terminated.
(Low enrollment)
Sponsor:
Collaborator:
AVVAA World Healthcare Products, Inc.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00143819
First received: August 31, 2005
Last updated: April 7, 2017
Last verified: April 2017
Results First Received: January 4, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Psoriasis
Eczema
Interventions: Drug: Neuroskin Forte
Drug: Placebo Application

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    1 (Left Side: Active; Right Side: Placebo)   2 (Left Side: Placebo; Right Side: Active)
STARTED   5   8 
COMPLETED   3   5 
NOT COMPLETED   2   3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Bilateral Comparison Group 1

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

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 Total of all reporting groups

Baseline Measures
   Bilateral Comparison Group 1   Bilateral Comparison Group 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   8   13 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      3  60.0%      5  62.5%      8  61.5% 
>=65 years      2  40.0%      3  37.5%      5  38.5% 
Age 
[Units: Years]
Mean (Full Range)
 66 
 (49 to 79) 
 61 
 (42 to 85) 
 63 
 (42 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  40.0%      3  37.5%      5  38.5% 
Male      3  60.0%      5  62.5%      8  61.5% 
Region of Enrollment 
[Units: Participants]
     
United States   5   8   13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the Visual Analog Scale (VAS) Score for Pruritus (Itching) at 8 Weeks   [ Time Frame: 8 weeks ]

2.  Secondary:   Number of Participants With a Psoriasis ½-Body Physician Global Assessment (PGA) Improvement of at Least 2 Levels   [ Time Frame: 8 weeks ]

3.  Secondary:   Number of Participants With an Eczema ½-Body Investigator Global Assessment (IGA) Improvement of at Least 2 Levels   [ Time Frame: 8 weeks ]

4.  Secondary:   Change in Target Lesion Scoring   [ Time Frame: 8 weeks ]

5.  Secondary:   Photography of Target Lesions   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
small sample size


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr M Magliocco
Organization: UMDNJ-Robert Wood Johnson Medical School
e-mail: maglioma@yahoo.com



Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00143819     History of Changes
Other Study ID Numbers: 5494
Study First Received: August 31, 2005
Results First Received: January 4, 2017
Last Updated: April 7, 2017