Allergy
Conditions
Keywords
Neo-Synalar, Patch Test, Sodium lauryl sulfate, Saline, Presensitization
Brief summary
A 48 hour patch test performed in healthy volunteers to determine the presensitization (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base), fluocinolone acetonide 0.025%) Cream . Subjects also receive a positive control (Sodium Lauryl Sulfate) and a negative control (Saline). The primary objective of this study is to determine if any subjects exhibit an allergic reaction which may be indicative of a pre-existing sensitization.
Detailed description
Following approximately 48 hours of continuous skin contact, the patch units and test material are removed at the testing facility. The test sites are evaluated for a significant reaction according to the ESS (Erythemal Scoring Scale). The test sites are also re-evaluated at 96 and 168 hours post-application (for late reaction) using the ESS.
Interventions
DRUGNeo-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.
OTHERSodium 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.
OTHERSaline
Saline 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.
Sponsors
Noah Rosenberg, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be 18 to 79 years inclusive. * Subjects must be able to understand and execute informed consent. * Female subjects must produce a negative pregnancy test. * Subjects must be capable of following directions. * Subjects must be considered reliable .
Exclusion criteria
* Subjects who are ill of health or taking medication that could influence the purpose, integrity, or outcome of the trial. * Female subjects who are pregnant. * Subjects with a history of adverse reactions to cosmetics, OTC (over the counter) drugs or other personal care products. * Subjects who have used topical or systemic steroids or antihistamines within 7 days prior to trial initiation or plan to use either during the duration of the trial. * Subjects with known allergy to neomycin, bacitracin, gentamicin, paromomycin, spectinomycin, streptomycin or tobramycin. * Subjects with known allergy to corticosteroid. * Subjects with a history of auto-immune disease (e.g. lupus, psoriatic arthritis, rheumatoid arthritis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS) | 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. |
Countries
United States
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| Patch Test Group 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. | 202 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did Not Consent to Participation | 2 |
| Overall Study | Did Not Meet Exclusionary Criteria | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Patch Test Group |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 31 Participants |
| Age, Categorical Between 18 and 65 years | 170 Participants |
| Age, Continuous | 48 years |
| Region of Enrollment United States | 202 participants |
| Sex: Female, Male Female | 155 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 202 |
| serious Total, serious adverse events | 0 / 202 |
Outcome results
Primary
Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS)
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patch Test Group | Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS) | 0 percentage of patients w allergic rxn |