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Trial record 3 of 49 for:    Sodium Lauryl Sulfate

Neo-Synalar Modified 48 Hour Patch Test

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ClinicalTrials.gov Identifier: NCT02168478
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : December 11, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Noah Rosenberg, MD, Medimetriks Pharmaceuticals, Inc

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Allergy
Interventions Drug: Neo-Synalar Cream
Other: Sodium Lauryl Sulfate Aqueous Solution (0.40%)
Other: Saline
Enrollment 206
Recruitment Details All subjects were recruited at single center- CPTC (Consumer Product Testing Corporation) located in Fairfield NJ.
Pre-assignment Details There was no wash-out or run-in period
Arm/Group Title Patch Test Group
Hide Arm/Group Description

All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.

Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.

Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.

Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.

Saline: Saline is applied to the absorbent pad portion of a

Period Title: Overall Study
Started 206
Completed 202
Not Completed 4
Reason Not Completed
Withdrawal by Subject             1
Did Not Consent to Participation             2
Did Not Meet Exclusionary Criteria             1
Arm/Group Title Patch Test Group
Hide Arm/Group Description

All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.

All test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.

Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied to upper back between the scapulae.

Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate applied to the absorbent pad portion of a semi-occlusive dressing and applied to upper back between the scapulae.

Saline: Saline is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae.

Overall Number of Baseline Participants 202
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants
<=18 years
1
   0.5%
Between 18 and 65 years
170
  84.2%
>=65 years
31
  15.3%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 202 participants
48
(18 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants
Female
155
  76.7%
Male
47
  23.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 202 participants
202
1.Primary Outcome
Title Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS)
Hide Description ESS is measured at 48, 96 and 168 hours post-application of study material. The Erythemal Scoring Scale (ESS) is defined as a 6 point scale (0-4). "0"= no visible erythema; "0.5"= slight, barely perceptible erythema; "1"= mild erythema; "2"= moderate erythema; "3"= marked erythema; "4"= severe erythema. An ESS score of 1 or greater that persists or worsens from one visit to the next is defined as pre-existing sensitization.
Time Frame 48, 96 and 168 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patch Test Group
Hide Arm/Group Description:

Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.

Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 mL of the positive, 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.

Saline: Approximately 0.2 mL of saline is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.

Overall Number of Participants Analyzed 202
Measure Type: Number
Unit of Measure: percentage of patients w allergic rxn
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patch Test Group
Hide Arm/Group Description

All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline. Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.

Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae.

Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae.

Saline: Approximately 0.2 ml of the saline is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae.

All-Cause Mortality
Patch Test Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patch Test Group
Affected / at Risk (%)
Total   0/202 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patch Test Group
Affected / at Risk (%)
Total   0/202 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Noah L. Rosenberg, MD, Chief Medical Officer
Organization: Medimetriks
Phone: 2019194083
EMail: Noahrosie@yahoo.com
Layout table for additonal information
Responsible Party: Noah Rosenberg, MD, Medimetriks Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02168478     History of Changes
Other Study ID Numbers: MTWC01-001
First Submitted: June 17, 2014
First Posted: June 20, 2014
Results First Submitted: September 25, 2015
Results First Posted: December 11, 2015
Last Update Posted: December 11, 2015