Allergic Contact DermatitisNCT01797562
Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents
A study testing Panels 1.3, 2.2 and 3.2 experimental allergens in people with Allergic Contact Dermatitis, run by Allerderm at 4 sites in United States.
Trial summary
The objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E. Test allergens in pediatric subjects aged 6-17 years old. In total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Allergic Contact Dermatitis
- What is being tested?
- Panels 1.3, 2.2 and 3.2 experimental allergens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Dec 2012to 8 Sep 2015
- Phase
- Interventional
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Symptoms and history potentially consistent with allergic contact dermatitis
- Children and adolescents 6-17 years of age, in general good health
- Adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion
- Informed consent must be signed and understood by subject. If underage, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations
Who cannot join
- Topical corticosteroid treatment during the last 7 days on or near the test area.
- Systemic treatment with corticosteroids or other immunosuppressives during the last 7 days.
- Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study
- Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks
- Acute dermatitis outbreak or dermatitis on or near the test area on the back
- Subjects unable to comply with activity restrictions (e.g. protecting test panels from excess moisture due to showering or vigorous activity)
- Subjects unable or unwilling to comply with multiple return visits
- Female subjects 15 years of age (or with onset of menarche) and older unable to consent to a urine pregnancy test, or those with a positive pregnancy test
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Anschutz Health and Wellness Center, University of Colorado
Aurora, Colorado, 80045
Dermatology Specialists
Louisville, Kentucky, 40202
Oregon Health & Science University
Portland, Oregon, 97239
Rady Children's Hospital
San Diego, California, 92123
About this study
Official title: Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)
The objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E. Test allergens in pediatric subjects aged 6-17 years old. In total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient.
Read the detailed description
The evaluation of 7 new allergens on panels 2.2 and 3.2, Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol was the original objective of the study. The protocol was amended to include evaluation of 4 reformulated allergens; neomycin sulfate, potassium dichromate, ethylenediamne dihydrochloride and fragrance mix.
- Conditions
- Allergic Contact Dermatitis
- Being tested
- Panels 1.3, 2.2 and 3.2 experimental allergens
- Keywords
- Contact dermatitis, Eczema
- Medical subject headings
- Dermatitis, Allergic Contact, Dermatitis, Contact, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panels 1.3, 2.2 and 3.2 experimental allergensDiagnostic test
Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application.
| Study group | Role | What they receive |
|---|---|---|
| Positive Response Rates: 7 new and 4 reformulated allergens | Experimental | Subjects will be patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated Receives: Diagnostic Test: Panels 1.3, 2.2 and 3.2 experimental allergens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores
Reactions at patch test sites were evaluated:Negative: No reaction, Irritant: Discrete, patchy, follicular, or homogenous erythema with no infiltration, Doubtful: Faint macular or homogenous erythema with no infiltration, 1+: Faint macular or homogenous erythema with no infiltration, 2+: Erythema, papules, infiltration, discrete vesicles 3+: Coalescing vesicles, bullous reaction
Measured: Investigator Determination of Positive Reaction: 21 days post application
Secondary outcomes (1)
Number of Participants With Late or Persistent Positive Patch Test Reactions
Late reactions are positive reactions that initially occur at 7-21 days after application of the panels.
Persistent reactions are positive reactions that persist from one visit to the next.
Numbers reported only include late or persistent positive patch test reactions. Not all positive reactions are late or persistent.
Measured: Day 7-21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study start10 Dec 2012
- Primary completion8 Sep 2015
- Study completion8 Sep 2015
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 Allergic Contact DermatitisStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3 T.R.U.E. Test panels were applied to the paraspinal regional of the back and were to be worn for approximately 48 hours. Post application evaluations were performed at days 3, 4, 7(+1) and 21(+2).
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allerderm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cory Dunnick, MD, Principal investigator, Anschutz Health and Wellness Center, University of Colorado, Aurora, COJoseph Fowler, MD, Principal investigator, Dermatology Specialists, Louisville, KYLawrence Eichenfield, MD, Principal investigator, Rady Children's Hospital, San DiegoPatricia Norris, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797562
- Sponsor's protocol ID
- SP 12 7NEW 401
- Status last verified
- Apr 2020
- First submitted
- 20 Feb 2013
- Last updated
- 21 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)
- ClinicalTrials.gov ID
- NCT01797562
- Acronym / sponsor ID
- SP 12 7NEW 401
- Conditions
- Allergic Contact Dermatitis
- Keywords
- Contact dermatitis, Eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- AllerdermIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2012 (actual)
- Primary completion
- 8 Sep 2015 (actual)
- Study completion
- 8 Sep 2015 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E. Test allergens in pediatric subjects aged 6-17 years old. In total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient.
Detailed description
The evaluation of 7 new allergens on panels 2.2 and 3.2, Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol was the original objective of the study. The protocol was amended to include evaluation of 4 reformulated allergens; neomycin sulfate, potassium dichromate, ethylenediamne dihydrochloride and fragrance mix.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3 T.R.U.E. Test panels were applied to the paraspinal regional of the back and were to be worn for approximately 48 hours. Post application evaluations were performed at days 3, 4, 7(+1) and 21(+2).
| Arm | Type | Receives |
|---|---|---|
| Positive Response Rates: 7 new and 4 reformulated allergens | Experimental | Diagnostic Test: Panels 1.3, 2.2 and 3.2 experimental allergensSubjects will be patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Symptoms and history potentially consistent with allergic contact dermatitis
- Children and adolescents 6-17 years of age, in general good health
- Adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion
- Informed consent must be signed and understood by subject. If underage, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations
Key exclusion criteria (8 listed)
- Topical corticosteroid treatment during the last 7 days on or near the test area.
- Systemic treatment with corticosteroids or other immunosuppressives during the last 7 days.
- Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study
- Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks
- Acute dermatitis outbreak or dermatitis on or near the test area on the back
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 |
|---|---|---|
| Panels 1.3, 2.2 and 3.2 experimental allergensThree allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application. | Diagnostic test | Positive Response Rates: 7 new and 4 reformulated allergens |
Primary outcome
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores
Time frame: Investigator Determination of Positive Reaction: 21 days post application
Reactions at patch test sites were evaluated:Negative: No reaction, Irritant: Discrete, patchy, follicular, or homogenous erythema with no infiltration, Doubtful: Faint macular or homogenous erythema with no infiltration, 1+: Faint macular or homogenous erythema with no infiltration, 2+: Erythema, papules, infiltration, discrete vesicles 3+: Coalescing vesicles, bullous reaction
1 secondary outcome
Number of Participants With Late or Persistent Positive Patch Test Reactions
Time frame: Day 7-21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- 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.
Cory Dunnick, MD principal investigator
Anschutz Health and Wellness Center, University of Colorado, Aurora, CO
Joseph Fowler, MD principal investigator
Dermatology Specialists, Louisville, KY
Lawrence Eichenfield, MD principal investigator
Rady Children's Hospital, San Diego
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panels 1.3, 2.2 and 3.2 experimental allergens in people with Allergic Contact Dermatitis, run by Allerderm at 4 sites 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 4 inclusion and 8 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 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2020). 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?
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores (time frame: Investigator Determination of Positive Reaction: 21 days post application). 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 21 Aug 2020.