An interventional study of Panels 1.3, 2.2 and 3.2 experimental allergens in Allergic Contact Dermatitis, sponsored by Allerderm. Completed at 4 sites in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-08-21.
Sponsored by Allerderm · Not applicable, Interventional, and Diagnostic
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.
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.
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's enrollment of 116 is above the median of 64 across 1,131 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →Allerderm is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Diagnostic Test: Panels 1.3, 2.2 and 3.2 experimental allergens
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.
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
Time frame: Investigator Determination of Positive Reaction: 21 days post application
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.
Time frame: Day 7-21
Subjects will be recruited from patients visiting dermatology, allergy or similar medical practices and clinics, and who are likely to require diagnostic patch testing. Study subjects must be otherwise healthy, and fulfill entry criteria.
| Milestone | Evaluation of T.R.U.E. Test Experimental Allergens |
|---|---|
| Started | 116 |
| Completed | 111 |
| Not completed | 5 |
| Withdrew: Protocol violation | 5 |
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
| Participants | Positive Response Rates: 7 New and 4 Reformulated Allergens |
|---|---|
| Neomycin sulfate — Negative | 49 |
| Neomycin sulfate — Positive | 3 |
| Neomycin sulfate — Irritant | 0 |
| Neomycin sulfate — Doubtful | 1 |
| Neomycin sulfate — Not Tested with this Allergen | 58 |
| Potassium dichromate — Negative | 50 |
| Potassium dichromate — Positive | 2 |
| Potassium dichromate — Irritant | 0 |
| Potassium dichromate — Doubtful | 1 |
| Potassium dichromate — Not Tested with this Allergen | 58 |
| Fragrance Mix — Negative | 48 |
| Fragrance Mix — Positive | 2 |
| Fragrance Mix — Irritant | 0 |
| Fragrance Mix — Doubtful | 3 |
| Fragrance Mix — Not Tested with this Allergen | 58 |
| Ethylenediamine — Negative | 53 |
| Ethylenediamine — Positive | 0 |
| Ethylenediamine — Irritant | 0 |
| Ethylenediamine — Doubtful | 0 |
| Ethylenediamine — Not Tested with this Allergen | 58 |
| MDBGN — Negative | 107 |
| MDBGN — Positive | 1 |
| MDBGN — Irritant | 0 |
| MDBGN — Doubtful | 3 |
| MDBGN — Not Tested with this Allergen | 0 |
| Gold — Negative | 69 |
| Gold — Positive | 31 |
| Gold — Irritant | 0 |
| Gold — Doubtful | 11 |
| Gold — Not Tested with this Allergen | 0 |
| Hydrocortisone — Negative | 106 |
| Hydrocortisone — Positive | 2 |
| Hydrocortisone — Irritant | 0 |
| Hydrocortisone — Doubtful | 3 |
| Hydrocortisone — Not Tested with this Allergen | 0 |
| Bacitracin — Negative | 90 |
| Bacitracin — Positive | 16 |
| Bacitracin — Irritant | 0 |
| Bacitracin — Doubtful | 5 |
| Bacitracin — Not Tested with this Allergen | 0 |
| Parthenolide — Negative | 97 |
| Parthenolide — Positive | 7 |
| Parthenolide — Irritant | 0 |
| Parthenolide — Doubtful | 7 |
| Parthenolide — Not Tested with this Allergen | 0 |
| Disperse Blue — Negative | 102 |
| Disperse Blue — Positive | 4 |
| Disperse Blue — Irritant | 0 |
| Disperse Blue — Doubtful | 5 |
| Disperse Blue — Not Tested with this Allergen | 0 |
| Bronopol — Negative | 89 |
| Bronopol — Positive | 19 |
| Bronopol — Irritant | 0 |
| Bronopol — Doubtful | 3 |
| Bronopol — Not Tested with this Allergen | 0 |
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.
| Participants | Evaluation of T.R.U.E. Test Experimental Allergens |
|---|---|
| Neomycin sulfate — Persistent Reactions | 2 |
| Neomycin sulfate — Late Reactions | 1 |
| Neomycin sulfate — Neither | 108 |
| Potassium dichromate — Persistent Reactions | 0 |
| Potassium dichromate — Late Reactions | 1 |
| Potassium dichromate — Neither | 110 |
| Fragrance mix — Persistent Reactions | 2 |
| Fragrance mix — Late Reactions | 0 |
| Fragrance mix — Neither | 109 |
| Ethylenediamine — Persistent Reactions | 0 |
| Ethylenediamine — Late Reactions | 0 |
| Ethylenediamine — Neither | 111 |
| MDBGN — Persistent Reactions | 0 |
| MDBGN — Late Reactions | 1 |
| MDBGN — Neither | 110 |
| Gold — Persistent Reactions | 15 |
| Gold — Late Reactions | 15 |
| Gold — Neither | 81 |
| Hydrocortisone — Persistent Reactions | 0 |
| Hydrocortisone — Late Reactions | 2 |
| Hydrocortisone — Neither | 109 |
| Bacitracin — Persistent Reactions | 9 |
| Bacitracin — Late Reactions | 7 |
| Bacitracin — Neither | 95 |
| Parthenolide — Persistent Reactions | 1 |
| Parthenolide — Late Reactions | 6 |
| Parthenolide — Neither | 104 |
| Disperse Blue — Persistent Reactions | 2 |
| Disperse Blue — Late Reactions | 2 |
| Disperse Blue — Neither | 107 |
| Bronopol — Persistent Reactions | 6 |
| Bronopol — Late Reactions | 13 |
| Bronopol — Neither | 92 |
Collected over Days 2-21. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Evaluation of T.R.U.E. Test Experimental Allergens | — | 1/116 (0.9%) | 47/116 (40.5%) |
| Event | Evaluation of T.R.U.E. Test Experimental Allergens |
|---|---|
| AppendicitisInfections and infestations | 1/116 |
| Event | Evaluation of T.R.U.E. Test Experimental Allergens |
|---|---|
| PruritusSkin and subcutaneous tissue disorders | 9/116 |
| NasopharyngitisInfections and infestations | 6/116 |
| RashSkin and subcutaneous tissue disorders | 4/116 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/116 |
| DermatitisSkin and subcutaneous tissue disorders | 2/116 |
| Staphylococcal infectionInfections and infestations | 2/116 |
| Chest painGeneral disorders | 1/116 |
| DiscomfortGeneral disorders | 1/116 |
| DizzinessNervous system disorders | 1/116 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/116 |
| Age, Continuous(years) | Positive Response Rates: 7 New and 4 Reformulated Allergens |
|---|---|
| Mean | 12.6 (6 to 17) |
| Sex: Female, Male(Participants) | Positive Response Rates: 7 New and 4 Reformulated Allergens |
|---|---|
| Female | 80 |
| Male | 36 |
| Ethnicity (NIH/OMB)(Participants) | Positive Response Rates: 7 New and 4 Reformulated Allergens |
|---|---|
| Hispanic or Latino | 44 |
| Not Hispanic or Latino | 72 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Positive Response Rates: 7 New and 4 Reformulated Allergens |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 13 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 78 |
| More than one race | 12 |
| Unknown or Not Reported | 5 |
| Region of Enrollment(participants) | Positive Response Rates: 7 New and 4 Reformulated Allergens |
|---|---|
| United States | 116 |
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Allerderm