AllergyPhase 4NCT02168478
Neo-Synalar Modified 48 Hour Patch Test
A Phase 4 study testing Neo-Synalar Cream, Sodium Lauryl Sulfate Aqueous Solution (0.40%) and Saline in people with Allergy, run by Noah Rosenberg, MD at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy
- What is being tested?
- Neo-Synalar Cream, Sodium Lauryl Sulfate Aqueous Solution (0.40%) and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael Caswell PhD., CCRC,CCRA
Fairfield, New Jersey, 07004
About this study
Official title: A Modified 48 Hour Patch Test of Neo-Synalar Cream, Sodium Lauryl Sulfate (Positive Control) and Saline (Negative Control)
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.
Read the 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.
- Conditions
- Allergy
- Being tested
- Neo-Synalar Cream, Sodium Lauryl Sulfate Aqueous Solution (0.40%), Saline
- Keywords
- Neo-Synalar, Patch Test, Sodium lauryl sulfate, Saline, Presensitization
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo-Synalar CreamDrug
Also called NS 0.5%(0.35% neomycin base)/ FA 0.025% 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%)Other
Also called SLS
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.
SalineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patch Test Group | Experimental | 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. Receives: Drug: Neo-Synalar Cream; Other: Sodium Lauryl Sulfate Aqueous Solution (0.40%); Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48, 96 and 168 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noah Rosenberg, MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Noah Rosenberg, MD, Medimetriks Pharmaceuticals, Inc
- Investigators
- Michael Caswell, Ph.D, Principal investigator, Consumer Product Testing Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168478
- Sponsor's protocol ID
- MTWC01-001
- Status last verified
- Nov 2015
- First submitted
- 17 Jun 2014
- Last updated
- 11 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified 48 Hour Patch Test of Neo-Synalar Cream, Sodium Lauryl Sulfate (Positive Control) and Saline (Negative Control)
- ClinicalTrials.gov ID
- NCT02168478
- Acronym / sponsor ID
- MTWC01-001
- Conditions
- Allergy
- Keywords
- Neo-Synalar, Patch Test, Sodium lauryl sulfate, Saline, Presensitization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Noah Rosenberg, MDIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Posted 11 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patch Test Group | Experimental | Drug: Neo-Synalar Cream, Other: Sodium Lauryl Sulfate Aqueous Solution (0.40%), Other: SalineAll 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 .
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neo-Synalar CreamAlso: NS 0.5%(0.35% neomycin base)/ FA 0.025% CreamApproximately 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. | Drug | Patch Test Group |
| Sodium Lauryl Sulfate Aqueous Solution (0.40%)Also: SLSApproximately 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. | Other | Patch Test Group |
| SalineSaline 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. | Other | Patch Test Group |
Primary outcome
Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Caswell, Ph.D principal investigator
Consumer Product Testing Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neo-Synalar Cream, Sodium Lauryl Sulfate Aqueous Solution (0.40%) and Saline in people with Allergy, run by Noah Rosenberg, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS) (time frame: 48, 96 and 168 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.