AllergyNCT07400718
Head-to-Head Comparison Study Between Different FDA Registered Allergy Skin Test Applicators
A study testing AllerTest-10 Multi-Head Skin Test Device, Skintestor OMNI Multi-Head Skin Test Device and Multi-Test II Multi-Head Skin Test Device in people with Allergy and Hypersensitivity, Immediate, run by QHSLab, Inc. at 1 site in United States.
Trial summary
This clinical study, titled "Head-to-Head Comparison Study between Different FDA Registered Allergy Skin Test Applicators," aims to compare the reliability and clinical performance of three skin prick test (SPT) devices: Allertest™ Multiple Skin Test Applicator, Lincoln Multi-Test II, and Greer Skintestor OMNI… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy, Hypersensitivity, Immediate, Ig-E Mediated Food
- What is being tested?
- AllerTest-10 Multi-Head Skin Test Device, Skintestor OMNI Multi-Head Skin Test Device and Multi-Test II Multi-Head Skin Test Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be entered into this study only if they meet all of the following criteria:
- Written and signed informed consent obtained before starting any protocol-specific procedures.
- Subjects willing to withhold antihistamines, Leukotriene antagonists and H2 antagonists for at least 1 week before testing to avoid masking the histamine reactions on the skin.
- Male or female between 18 to 60 65 years, inclusive.
- Ability to comply with the study procedures and visit schedule.
Who cannot join
- Patients will NOT be entered into this study if they meet any of the following criteria:
- Anaphylactic reaction (constitutional) after the previous skin test with the same allergen
- Acute fever
- Systemic disease with acute manifestation or decompensation
- Abnormal skin condition in the area to be tested (such as eczema sunburn condition after sunbathing)
- Pregnancy
Show all 10Show fewer
- Presence of dermatographism, severe atopic dermatitis, or use of tricyclic antidepressants.
- Current use of beta-blockers
- Known hypersensitivity to any component of the test solutions (histamine or glycerin).
- Participation in another clinical study within 30 days before enrollment. Participation in another clinical study within 30 days before enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
This clinical study, titled "Head-to-Head Comparison Study between Different FDA Registered Allergy Skin Test Applicators," aims to compare the reliability and clinical performance of three skin prick test (SPT) devices: Allertest™ Multiple Skin Test Applicator, Lincoln Multi-Test II, and Greer Skintestor OMNI Applicator. The primary objective is to evaluate the consistency and accuracy of these devices in allergy testing.
Read the detailed description
Background and Rationale:
Percutaneous allergy skin testing remains the gold standard diagnostic method for IgE-mediated allergic disease. Multiple-head skin prick test (SPT) devices enable simultaneous application of multiple allergens, improving testing efficiency while potentially reducing patient discomfort. However, significant inter-device variability exists among commercially available devices, with important implications for diagnostic accuracy and clinical interpretation.
Intra-device variability-inconsistent responses across individual test heads within a single device-represents a particularly concerning phenomenon that may lead to physician misinterpretation and potentially inappropriate treatment decisions. Such variability can be attributed to manufacturing factors including tooling mold precision, molding equipment quality, and process controls during production. Prior research has demonstrated that devices with lower finished product variability exhibit improved clinical performance characterized by reduced false-positive reactions to negative controls.
Study Design:
This prospective, single-visit, head-to-head device comparison study employed a paired design in which each participant served as their own control, receiving testing with two devices simultaneously-one device applied to each forearm. This within-subject design minimizes inter-individual variability and provides robust comparative data.
Participants were allocated into two comparison groups based on device head configuration: a 10-head device comparison (n=13) and an 8-head device comparison (n=17). Device assignment to right versus left forearm was randomized. Testing personnel were blinded to solution contents (histamine versus glycerin) during application, and a separate evaluator blinded to device assignment recorded wheal measurements.
Study Procedures:
All testing was performed by trained personnel in accordance with standard percutaneous skin testing protocols. Histamine dihydrochloride (1 mg/mL; ALK-Abello) served as the positive control and glycerin solution (ALK-Abello) served as the negative control. Devices were applied to the volar forearm surfaces with standardized pressure and technique. Test sites were maintained at least 2 cm apart to prevent cross-contamination between histamine and glycerin reactions.
Wheal measurements were obtained 15-20 minutes post-application using the mean diameter method (average of longest diameter and its perpendicular midpoint), consistent with established international guidelines. Pain assessment was performed immediately following device application.
Statistical Considerations:
Paired comparisons between devices were analyzed using Wilcoxon signed-rank tests for continuous variables and McNemar's test for dichotomous outcomes. Intra-device variability was quantified using the coefficient of variation (CV) calculated across test heads, with lower values indicating greater consistency. Exact binomial (Clopper-Pearson) confidence intervals were calculated for sensitivity and specificity estimates. Statistical significance was set at α=0.05 (two-sided).
Clinical Significance:
This study addresses an important knowledge gap regarding comparative clinical performance of multi-head allergy testing devices. Results provide evidence-based data to inform device selection decisions that may impact diagnostic accuracy, patient comfort, and reliability of allergen identification in clinical allergy practice.
- Conditions
- Allergy, Hypersensitivity, Immediate, Ig-E Mediated Food
- Being tested
- AllerTest-10 Multi-Head Skin Test Device, Skintestor OMNI Multi-Head Skin Test Device, Multi-Test II Multi-Head Skin Test Device, AllerTest-8 Multi-Head Skin Test Device
- Keywords
- Allergy skin testing, Skin prick test, Multi-head skin test device, Device comparison, Diagnostic accuracy, Sensitivity and specificity, Intra-device variability
- Medical subject headings
- Hypersensitivity, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllerTest-10 Multi-Head Skin Test DeviceDevice
Also called AllerTest 10-head
FDA-cleared 10-head percutaneous skin test applicator manufactured by MedScience Research Group, Inc., distributed by ALK Abello, Inc. The device consists of 10 individual test heads arranged in a linear array, each with a standardized needle length designed to penetrate the epidermis without drawing blood. Applied with standardized pressure for simultaneous delivery of 10 test substances (histamine and glycerin controls in this study). Single-use, disposable device.
Skintestor OMNI Multi-Head Skin Test DeviceDevice
FDA-cleared 10-head percutaneous skin test applicator manufactured by Greer Laboratories, Inc. The device consists of 10 individual test heads arranged in a linear array for simultaneous application of multiple allergens and controls. Applied with standardized pressure for delivery of histamine and glycerin controls in this study. Single-use, disposable device.
Multi-Test II Multi-Head Skin Test DeviceDevice
FDA-cleared 8-head percutaneous skin test applicator manufactured by Lincoln Diagnostics, Inc. The device consists of 8 individual test heads arranged in a linear array for simultaneous application of multiple allergens and controls. Applied with standardized pressure for delivery of histamine and glycerin controls in this study. Single-use, disposable device.
AllerTest-8 Multi-Head Skin Test DeviceDevice
FDA-cleared 8-head percutaneous skin test applicator manufactured by MedScience Research Group, Inc., distributed by ALK Abello, Inc. The device consists of 8 individual test heads arranged in a linear array, each with a standardized needle length designed to penetrate the epidermis without drawing blood. Applied with standardized pressure for simultaneous delivery of 8 test substances (histamine and glycerin controls in this study). Single-use, disposable device.
| Study group | Role | What they receive |
|---|---|---|
| AllerTest Device | Experimental | Participants receive percutaneous allergy skin testing using an AllerTest multi-head device (either AllerTest-10 or AllerTest-8, manufactured by MedScience Research Group, Inc., distributed by ALK Abello, Inc.). The device is applied to one randomized forearm with a standardized histamine positive control (10 mg/mL histamine base) and a glycerin negative control (50% glycerin in saline). Outcomes measured include procedural pain (VAS 0-10), histamine wheal size at 15 minutes, glycerin wheal size at 15 minutes, sensitivity (proportion of histamine sites ≥3 mm), specificity (proportion of glycerin sites <3 mm), and intra-device variability (coefficient of variation across test heads). Receives: Device: AllerTest-10 Multi-Head Skin Test Device; Device: AllerTest-8 Multi-Head Skin Test Device |
| Comparator Device | Active comparator | Participants receive percutaneous allergy skin testing using a comparator multi-head device (either Skintestor OMNI manufactured by Greer Laboratories, Inc., or Multi-Test II manufactured by Lincoln Diagnostics, Inc.). The device is applied simultaneously to the opposite forearm with identical standardized histamine positive control (10 mg/mL histamine base) and glycerin negative control (50% glycerin in saline). The same outcomes are measured to enable direct paired comparison: procedural pain (VAS 0-10), histamine wheal size at 15 minutes, glycerin wheal size at 15 minutes, sensitivity, specificity, and intra-device variability. Receives: Device: Skintestor OMNI Multi-Head Skin Test Device; Device: Multi-Test II Multi-Head Skin Test Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment Using Visual Analog Scale (VAS)
Procedural pain assessed immediately after device application using a 0-10 Visual Analog Scale (VAS), where 0 represents no pain and 10 represents unspeakable pain. Lower scores indicate less pain and better tolerability.
Measured: Immediately after device application (within 1 minute of skin test procedure)
Sensitivity (Histamine Positive Control Performance)
Proportion of histamine control sites producing wheal ≥3 mm diameter at 15 minutes post-application. A wheal of ≥3 mm is the standard threshold for a positive allergic reaction. Higher sensitivity indicates better device performance in reliably eliciting positive control responses. Calculated as: (number of histamine sites with wheal ≥3 mm) / (total number of histamine sites tested) × 100%.
Measured: 15 minutes after device application
Specificity (Glycerin Negative Control Performance)
Proportion of glycerin control sites producing wheal <3 mm diameter at 15 minutes post-application. Glycerin should not produce a wheal response; a result <3 mm confirms appropriate negative control performance and absence of non-specific mechanical irritation. Higher specificity indicates better device performance. Calculated as: (number of glycerin sites with wheal <3 mm) / (total number of glycerin sites tested) × 100%.
Measured: 15 minutes after device application
Secondary outcomes (4)
Intra-Device Variability
Coefficient of variation (CV) of histamine wheal sizes across all test heads within each device, calculated as CV = (standard deviation / mean) × 100%. Lower CV values indicate greater consistency and precision across test heads within the same device. This measure reflects the reliability of allergen delivery across multiple heads of a single device application.
Measured: 15 minutes after device application
Mean Histamine Wheal Size
Mean diameter (in millimeters) of wheals produced by histamine positive control across all test heads of each device. Wheal diameter measured using the mean diameter method (average of longest diameter and its perpendicular midpoint). Larger wheals indicate stronger positive control response.
Measured: 15 minutes after device application
Mean Glycerin Wheal Size
Mean diameter (in millimeters) of wheals produced by glycerin negative control across all test heads of each device. Wheal diameter measured using the mean diameter method (average of longest diameter and its perpendicular midpoint). Smaller measurements (ideally 0 mm) indicate appropriate negative control performance with minimal non-specific irritation.
Measured: 15 minutes after device application
Proportion of Subjects with Clinically Significant Pain
Proportion of participants experiencing more than mild pain, defined as a score greater than 4 on the Visual Analog Scale (VAS) for pain. The VAS ranges from 0 (no pain) to 10 (unspeakable pain), with higher scores indicating worse pain. A threshold of >4 represents approximately 40% of the scale and indicates clinically meaningful discomfort. Lower percentages indicate better device tolerability across the study population. Reported as percentage with 95% exact binomial confidence intervals.
Measured: Immediately after device application (within 1 minute of skin test procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start12 Nov 2025
- Primary completion30 Nov 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study employed a paired comparison design with each participant serving as their own control. Participants were assigned to one of two device comparison groups: (1) 10-head device comparison (AllerTest-10 vs. Skintestor OMNI, n=13), or (2) 8-head device comparison (AllerTest-8 vs. Multi-Test II, n=17). Within each comparison group, both devices were applied simultaneously-one to each forearm-with randomized left/right assignment. Each device was loaded with standardized histamine positive control and glycerin negative control. This within-subject design eliminates inter-subject variability in skin reactivity, providing robust paired comparisons of device performance on pain perception, control accuracy (sensitivity/specificity), and intra-device consistency.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- QHSLab, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ALK-Abelló A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400718
- Sponsor's protocol ID
- 33-098
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Platts-Mills TA, Woodfolk JA. Rise in asthma cases. Science. 1997 Nov 7;278(5340):1001. doi: 10.1126/science.278.5340.997c. No abstract available.
PubMed 9381194Arbes SJ Jr, Gergen PJ, Elliott L, Zeldin DC. Prevalences of positive skin test responses to 10 common allergens in the US population: results from the third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2005 Aug;116(2):377-83. doi: 10.1016/j.jaci.2005.05.017.
PubMed 16083793Cox L, Williams B, Sicherer S, Oppenheimer J, Sher L, Hamilton R, Golden D; American College of Allergy, Asthma and Immunology Test Task Force; American Academy of Allergy, Asthma and Immunology Specific IgE Test Task Force. Pearls and pitfalls of allergy diagnostic testing: report from the American College of Allergy, Asthma and Immunology/American Academy of Allergy, Asthma and Immunology Specific IgE Test Task Force. Ann Allergy Asthma Immunol. 2008 Dec;101(6):580-92.
PubMed 19119701Antunes J, Borrego L, Romeira A, Pinto P. Skin prick tests and allergy diagnosis. Allergol Immunopathol (Madr). 2009 May-Jun;37(3):155-64. doi: 10.1016/S0301-0546(09)71728-8. Epub 2009 Jul 23.
PubMed 19769849Bernstein IL, Li JT, Bernstein DI, Hamilton R, Spector SL, Tan R, Sicherer S, Golden DB, Khan DA, Nicklas RA, Portnoy JM, Blessing-Moore J, Cox L, Lang DM, Oppenheimer J, Randolph CC, Schuller DE, Tilles SA, Wallace DV, Levetin E, Weber R; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology. Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008 Mar;100(3 Suppl 3):S1-148. doi: 10.1016/s1081-1206(10)60305-5. No abstract available.
PubMed 18431959
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-to-Head Comparison Study Between Different FDA Registered Allergy Skin Test Applicators
- ClinicalTrials.gov ID
- NCT07400718
- Acronym / sponsor ID
- 33-098
- Conditions
- Allergy, Hypersensitivity, Immediate, Ig-E Mediated Food
- Keywords
- Allergy skin testing, Skin prick test, Multi-head skin test device, Device comparison, Diagnostic accuracy, Sensitivity and specificity, Intra-device variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- QHSLab, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ALK-Abelló A/S
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study, titled "Head-to-Head Comparison Study between Different FDA Registered Allergy Skin Test Applicators," aims to compare the reliability and clinical performance of three skin prick test (SPT) devices: Allertest™ Multiple Skin Test Applicator, Lincoln Multi-Test II, and Greer Skintestor OMNI Applicator. The primary objective is to evaluate the consistency and accuracy of these devices in allergy testing.
Detailed description
Background and Rationale:
Percutaneous allergy skin testing remains the gold standard diagnostic method for IgE-mediated allergic disease. Multiple-head skin prick test (SPT) devices enable simultaneous application of multiple allergens, improving testing efficiency while potentially reducing patient discomfort. However, significant inter-device variability exists among commercially available devices, with important implications for diagnostic accuracy and clinical interpretation.
Intra-device variability-inconsistent responses across individual test heads within a single device-represents a particularly concerning phenomenon that may lead to physician misinterpretation and potentially inappropriate treatment decisions. Such variability can be attributed to manufacturing factors including tooling mold precision, molding equipment quality, and process controls during production. Prior research has demonstrated that devices with lower finished product variability exhibit improved clinical performance characterized by reduced false-positive reactions to negative controls.
Study Design:
This prospective, single-visit, head-to-head device comparison study employed a paired design in which each participant served as their own control, receiving testing with two devices simultaneously-one device applied to each forearm. This within-subject design minimizes inter-individual variability and provides robust comparative data.
Participants were allocated into two comparison groups based on device head configuration: a 10-head device comparison (n=13) and an 8-head device comparison (n=17). Device assignment to right versus left forearm was randomized. Testing personnel were blinded to solution contents (histamine versus glycerin) during application, and a separate evaluator blinded to device assignment recorded wheal measurements.
Study Procedures:
All testing was performed by trained personnel in accordance with standard percutaneous skin testing protocols. Histamine dihydrochloride (1 mg/mL; ALK-Abello) served as the positive control and glycerin solution (ALK-Abello) served as the negative control. Devices were applied to the volar forearm surfaces with standardized pressure and technique. Test sites were maintained at least 2 cm apart to prevent cross-contamination between histamine and glycerin reactions.
Wheal measurements were obtained 15-20 minutes post-application using the mean diameter method (average of longest diameter and its perpendicular midpoint), consistent with established international guidelines. Pain assessment was performed immediately following device application.
Statistical Considerations:
Paired comparisons between devices were analyzed using Wilcoxon signed-rank tests for continuous variables and McNemar's test for dichotomous outcomes. Intra-device variability was quantified using the coefficient of variation (CV) calculated across test heads, with lower values indicating greater consistency. Exact binomial (Clopper-Pearson) confidence intervals were calculated for sensitivity and specificity estimates. Statistical significance was set at α=0.05 (two-sided).
Clinical Significance:
This study addresses an important knowledge gap regarding comparative clinical performance of multi-head allergy testing devices. Results provide evidence-based data to inform device selection decisions that may impact diagnostic accuracy, patient comfort, and reliability of allergen identification in clinical allergy practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study employed a paired comparison design with each participant serving as their own control. Participants were assigned to one of two device comparison groups: (1) 10-head device comparison (AllerTest-10 vs. Skintestor OMNI, n=13), or (2) 8-head device comparison (AllerTest-8 vs. Multi-Test II, n=17). Within each comparison group, both devices were applied simultaneously-one to each forearm-with randomized left/right assignment. Each device was loaded with standardized histamine positive control and glycerin negative control. This within-subject design eliminates inter-subject variability in skin reactivity, providing robust paired comparisons of device performance on pain perception, control accuracy (sensitivity/specificity), and intra-device consistency.
| Arm | Type | Receives |
|---|---|---|
| AllerTest Device | Experimental | Device: AllerTest-10 Multi-Head Skin Test Device, Device: AllerTest-8 Multi-Head Skin Test DeviceParticipants receive percutaneous allergy skin testing using an AllerTest multi-head device (either AllerTest-10 or AllerTest-8, manufactured by MedScience Research Group, Inc., distributed by ALK Abello, Inc.). The device is applied to one randomized forearm with a standardized histamine positive control (10 mg/mL histamine base) and a glycerin negative control (50% glycerin in saline). Outcomes measured include procedural pain (VAS 0-10), histamine wheal size at 15 minutes, glycerin wheal size at 15 minutes, sensitivity (proportion of histamine sites ≥3 mm), specificity (proportion of glycerin sites <3 mm), and intra-device variability (coefficient of variation across test heads). |
| Comparator Device | Active comparator | Device: Skintestor OMNI Multi-Head Skin Test Device, Device: Multi-Test II Multi-Head Skin Test DeviceParticipants receive percutaneous allergy skin testing using a comparator multi-head device (either Skintestor OMNI manufactured by Greer Laboratories, Inc., or Multi-Test II manufactured by Lincoln Diagnostics, Inc.). The device is applied simultaneously to the opposite forearm with identical standardized histamine positive control (10 mg/mL histamine base) and glycerin negative control (50% glycerin in saline). The same outcomes are measured to enable direct paired comparison: procedural pain (VAS 0-10), histamine wheal size at 15 minutes, glycerin wheal size at 15 minutes, sensitivity, specificity, and intra-device variability. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients will be entered into this study only if they meet all of the following criteria:
Key exclusion criteria (10 listed)
- Patients will NOT be entered into this study if they meet any of the following criteria:
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 |
|---|---|---|
| AllerTest-10 Multi-Head Skin Test DeviceAlso: AllerTest 10-headFDA-cleared 10-head percutaneous skin test applicator manufactured by MedScience Research Group, Inc., distributed by ALK Abello, Inc. The device consists of 10 individual test heads arranged in a linear array, each with a standardized needle length designed to penetrate the epidermis without drawing blood. Applied with standardized pressure for simultaneous delivery of 10 test substances (histamine and glycerin controls in this study). Single-use, disposable device. | Device | AllerTest Device |
| Skintestor OMNI Multi-Head Skin Test DeviceFDA-cleared 10-head percutaneous skin test applicator manufactured by Greer Laboratories, Inc. The device consists of 10 individual test heads arranged in a linear array for simultaneous application of multiple allergens and controls. Applied with standardized pressure for delivery of histamine and glycerin controls in this study. Single-use, disposable device. | Device | Comparator Device |
| Multi-Test II Multi-Head Skin Test DeviceFDA-cleared 8-head percutaneous skin test applicator manufactured by Lincoln Diagnostics, Inc. The device consists of 8 individual test heads arranged in a linear array for simultaneous application of multiple allergens and controls. Applied with standardized pressure for delivery of histamine and glycerin controls in this study. Single-use, disposable device. | Device | Comparator Device |
| AllerTest-8 Multi-Head Skin Test DeviceFDA-cleared 8-head percutaneous skin test applicator manufactured by MedScience Research Group, Inc., distributed by ALK Abello, Inc. The device consists of 8 individual test heads arranged in a linear array, each with a standardized needle length designed to penetrate the epidermis without drawing blood. Applied with standardized pressure for simultaneous delivery of 8 test substances (histamine and glycerin controls in this study). Single-use, disposable device. | Device | AllerTest Device |
Primary outcome
Pain Assessment Using Visual Analog Scale (VAS)
Time frame: Immediately after device application (within 1 minute of skin test procedure)
Procedural pain assessed immediately after device application using a 0-10 Visual Analog Scale (VAS), where 0 represents no pain and 10 represents unspeakable pain. Lower scores indicate less pain and better tolerability.
Sensitivity (Histamine Positive Control Performance)
Time frame: 15 minutes after device application
Proportion of histamine control sites producing wheal ≥3 mm diameter at 15 minutes post-application. A wheal of ≥3 mm is the standard threshold for a positive allergic reaction. Higher sensitivity indicates better device performance in reliably eliciting positive control responses. Calculated as: (number of histamine sites with wheal ≥3 mm) / (total number of histamine sites tested) × 100%.
Specificity (Glycerin Negative Control Performance)
Time frame: 15 minutes after device application
Proportion of glycerin control sites producing wheal <3 mm diameter at 15 minutes post-application. Glycerin should not produce a wheal response; a result <3 mm confirms appropriate negative control performance and absence of non-specific mechanical irritation. Higher specificity indicates better device performance. Calculated as: (number of glycerin sites with wheal <3 mm) / (total number of glycerin sites tested) × 100%.
4 secondary outcomes
Intra-Device Variability
Time frame: 15 minutes after device application
Mean Histamine Wheal Size
Time frame: 15 minutes after device application
Mean Glycerin Wheal Size
Time frame: 15 minutes after device application
Proportion of Subjects with Clinically Significant Pain
Time frame: Immediately after device application (within 1 minute of skin test procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Results publication: PubMed 9381194Platts-Mills TA, Woodfolk JA. Rise in asthma cases. Science. 1997 Nov 7;278(5340):1001. doi: 10.1126/science.278.5340.997c. No abstract available.
- Results publication: PubMed 16083793Arbes SJ Jr, Gergen PJ, Elliott L, Zeldin DC. Prevalences of positive skin test responses to 10 common allergens in the US population: results from the third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2005 Aug;116(2):377-83. doi: 10.1016/j.jaci.2005.05.017.
- Results publication: PubMed 19119701Cox L, Williams B, Sicherer S, Oppenheimer J, Sher L, Hamilton R, Golden D; American College of Allergy, Asthma and Immunology Test Task Force; American Academy of Allergy, Asthma and Immunology Specific IgE Test Task Force. Pearls and pitfalls of allergy diagnostic testing: report from the American College of Allergy, Asthma and Immunology/American Academy of Allergy, Asthma and Immunology Specific IgE Test Task Force. Ann Allergy Asthma Immunol. 2008 Dec;101(6):580-92.
- Results publication: PubMed 19769849Antunes J, Borrego L, Romeira A, Pinto P. Skin prick tests and allergy diagnosis. Allergol Immunopathol (Madr). 2009 May-Jun;37(3):155-64. doi: 10.1016/S0301-0546(09)71728-8. Epub 2009 Jul 23.
- Results publication: PubMed 18431959Bernstein IL, Li JT, Bernstein DI, Hamilton R, Spector SL, Tan R, Sicherer S, Golden DB, Khan DA, Nicklas RA, Portnoy JM, Blessing-Moore J, Cox L, Lang DM, Oppenheimer J, Randolph CC, Schuller DE, Tilles SA, Wallace DV, Levetin E, Weber R; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology. Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008 Mar;100(3 Suppl 3):S1-148. doi: 10.1016/s1081-1206(10)60305-5. No abstract available.
- Asthma and Allergy Foundation of America. CDC Fast Facts A-ZLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AllerTest-10 Multi-Head Skin Test Device, Skintestor OMNI Multi-Head Skin Test Device and Multi-Test II Multi-Head Skin Test Device in people with Allergy and Hypersensitivity, Immediate, run by QHSLab, Inc. 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 10 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 12 Feb 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Assessment Using Visual Analog Scale (VAS) (time frame: Immediately after device application (within 1 minute of skin test procedure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07400718, which also lists 5 linked publications.
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 12 Feb 2026.