Trial Outcomes & Findings for Neo-Synalar Modified 48 Hour Patch Test (NCT NCT02168478)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

206 participants

Primary outcome timeframe

48, 96 and 168 Hours

Results posted on

2015-12-11

Participant Flow

All subjects were recruited at single center- CPTC (Consumer Product Testing Corporation) located in Fairfield NJ.

There was no wash-out or run-in period

Participant milestones

Participant milestones
Measure	Patch Test Group 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
Overall Study STARTED	206
Overall Study COMPLETED	202
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Patch Test Group 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
Overall Study Withdrawal by Subject	1
Overall Study Did Not Consent to Participation	2
Overall Study Did Not Meet Exclusionary Criteria	1

Baseline Characteristics

Neo-Synalar Modified 48 Hour Patch Test

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patch Test Group n=202 Participants 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.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	170 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants
Age, Continuous	48 years n=5 Participants
Sex: Female, Male Female	155 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Region of Enrollment United States	202 participants n=5 Participants

PRIMARY outcome

Timeframe: 48, 96 and 168 Hours

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.

Outcome measures

Outcome measures
Measure	Patch Test Group n=202 Participants 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.
Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS)	0 percentage of patients w allergic rxn

Adverse Events

Patch Test Group

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

Noah L. Rosenberg, MD, Chief Medical Officer

Medimetriks

Phone: 2019194083

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place