Contact DermatitisPhase 2NCT00640250

Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response

A Phase 2 study testing T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens in people with Contact Dermatitis, run by Allerderm at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

We propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a clinical history of contact dermatitis and a… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Contact Dermatitis
What is being tested?: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 2 sitesin 2 countries
Study dates: Apr 2008to Sep 2009
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to Bronopol OR Current or previous symptoms and/or history consistent with allergic contact dermatitis, and a positive patch test (within the past 5 years) to Disperse blue 106 or Disperse blue 106/124 allergen mix.
All subjects must be adults (18 years of age or older) and otherwise in good health.
Premenopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion.
Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.

Who cannot join

Subjects unable to meet inclusion requirements.
Women who are breastfeeding or pregnant.
Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area.
Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents.
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 patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
Subject participation in clinical trials of investigational drugs, treatments or devices other than T.R.U.E. Test during this study or 3 weeks prior to inclusion in this study.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Dermatology Specialists PSC
Louisville, Kentucky, 40202-1864

Other trials in United States

Denmark1 site

Odense University Hospital
Odense C, DK-5000

Other trials in Denmark

About this study

Official title: Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Bronopol and Disperse Blue 106 Dose Response Study

Read the detailed description

Primary endpoint:

To evaluate the diagnostic performance of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:

Determination of the lowest concentration eliciting positive skin reactions (+1 or +2) in 70-90% of sensitive subjects.
Frequency of positive, negative, doubtful and irritant reactions for each allergen and tested concentration.
Concordance/discordance as compared to the corresponding reference petrolatum allergen.

Secondary endpoint:

To evaluate the safety of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:

The frequency of tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning.
The frequency and characterization of adverse events and serious adverse events.
The frequency and characterization of late and/or persistent reactions.

Conditions: Contact Dermatitis
Being tested: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens
Keywords: Dermatitis, Contact, Bronopol, Disperse Blue 106
Medical subject headings: Dermatitis, Contact, Dermatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T.R.U.E. TEST® Skin Patch Test: Dose Response AllergensBiological
Also called T.R.U.E. TEST® Skin Patch Test: Panel 3.2
Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2
Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.

Study groups in NCT00640250
Study group	Role	What they receive
Sensitives	Experimental	Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria. Receives: Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnostic Performance: Optimal Test Allergen Concentration
Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects
Measured: Visits 3-5: 3-21 days after application
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects
Measured: Visit 3: 3 days after application
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects
Measured: Visit 4: 7 days after application
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects
Measured: Visit 3: 3 days after application
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects
Measured: Visit 4: 7 days after application
Concordance Between Investigational Allergen and Reference Allergen
Concordance between disperse blue or bronopol and the respective reference petrolatum allergen
Measured: Visit 5: 21 days after patch application

Secondary outcomes (2)

Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning
Percentage of subjects who exhibited irritation and itching or burning at patch removal (entire panel is evaluated) and late/persistent reactions.
Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
Measured: Day 2-21
Adverse Events
The adverse event-reporting period began at application and ended with the Day 21 visit. Adverse events were followed until they resolved. Serious adverse events and those assessed by the investigator as possibly related to the investigational product were to be followed until they resolved or until the investigator assessed them as chronic or stable.
Measured: Days 0-21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Sep 2009

First posted21 Mar 2008 (estimated)
Study startApr 2008
Primary completionMar 2009
Study completionSep 2009

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 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 2
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00640250
Sponsor's protocol ID: Mekos 07 2P3.2 201
Other IDs: 2007-007130-19, WIRB Pr. No.: 20072233
Status last verified: Apr 2018
First submitted: 3 Mar 2008
Last updated: 9 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Not yet recruiting
Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
Allergic Contact Dermatitis (ACD)
Recruiting
Glycyrrhetinic Acid and Acute Irritant Dermatitis
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Recruiting
Exploring Skin Barrier Function, Recurrence of Diabetes Device-Related Contact Dermatitis, and Evaluation of Hydrocolloid and Silicone-Based Patches for Its Prevention in Children and Adolescents With Type 1 Diabetes
Contact Dermatitis, Type 1 Diabetes Mellitus
Not yet recruitingPhase 4
Reliability of Expired Allergens in Patch Testing: A Comparative Study With Non-Expired Series
Allergic Contact Dermatitis

All Contact Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2018. 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 Allergens: Bronopol and Disperse Blue 106 Dose Response Study
ClinicalTrials.gov ID: NCT00640250
Acronym / sponsor ID: Mekos 07 2P3.2 201
Conditions: Contact Dermatitis
Keywords: Dermatitis, Contact, Bronopol, Disperse Blue 106
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: AllerdermIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Mar 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 21 Mar 2008 (estimated)
Results: Posted 9 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary endpoint:

Determination of the lowest concentration eliciting positive skin reactions (+1 or +2) in 70-90% of sensitive subjects.
Frequency of positive, negative, doubtful and irritant reactions for each allergen and tested concentration.
Concordance/discordance as compared to the corresponding reference petrolatum allergen.

Secondary endpoint:

The frequency of tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning.
The frequency and characterization of adverse events and serious adverse events.
The frequency and characterization of late and/or persistent reactions.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sensitives	Experimental	Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response AllergensSubjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to Bronopol OR Current or previous symptoms and/or history consistent with allergic contact dermatitis, and a positive patch test (within the past 5 years) to Disperse blue 106 or Disperse blue 106/124 allergen mix.
All subjects must be adults (18 years of age or older) and otherwise in good health.
Premenopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion.
Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.

Key exclusion criteria (8 listed)

Subjects unable to meet inclusion requirements.
Women who are breastfeeding or pregnant.
Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area.
Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents.
Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.

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
T.R.U.E. TEST® Skin Patch Test: Dose Response AllergensAlso: T.R.U.E. TEST® Skin Patch Test: Panel 3.2Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2 Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.	Biological	Sensitives

Primary outcome

Diagnostic Performance: Optimal Test Allergen Concentration
Time frame: Visits 3-5: 3-21 days after application
Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Time frame: Visit 3: 3 days after application
Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Time frame: Visit 4: 7 days after application
Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Time frame: Visit 3: 3 days after application
Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Time frame: Visit 4: 7 days after application
Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects
Concordance Between Investigational Allergen and Reference Allergen
Time frame: Visit 5: 21 days after patch application
Concordance between disperse blue or bronopol and the respective reference petrolatum allergen

2 secondary outcomes

Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning
Time frame: Day 2-21
Adverse Events
Time frame: Days 0-21

Results and safety

Results posted to the registry on 9 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sensitives	48	48

Primary outcome: Diagnostic Performance: Optimal Test Allergen Concentration

Time frame: Visits 3-5: 3-21 days after application. Number. Unit: percentage of participants

Measure	Disperse Blue 0.017 mg/cm2 n = 21	Disperse Blue 0.050 mg/cm2 n = 21	Disperse Blue 0.150 mg/cm2 n = 21	Bronopol 0.125 mg/cm2 n = 26	Bronopol 0.250 mg/cm2 n = 26	Bronopol 0.500 mg/cm2 n = 26	Bronopol 0.750 mg/cm2 n = 26
Value	38.1	47.6	52.4	30.8	23.1	46.2	61.5

Population analysed: Percentage is based on subjects sensitive to each allergen. Results from one subject not included due to no past history of positive patch test.

Primary outcome: Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration

Time frame: Visit 3: 3 days after application. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Disperse Blue 0.017 mg/cm2 Positive Reactions n = 48	Disperse Blue 0.050 mg/cm2 Positive Reactions n = 48	Disperse Blue 0.150 mg/cm2 Positive Reactions n = 48	Negative Control Positive Reactions n = 48	Disperse Blue 0.017 Negative Reactions n = 48	Disperse Blue 0.050 mg/cm2 Negative Reactions n = 48	Disperse Blue 0.150 mg/cm2 Negative Reactions n = 48	Negative Control Negative Reactions n = 48	Disperse Blue 0.017 mg/cm2 Irritant Reactions n = 48	Disperse Blue 0.050 mg/cm2 Irritant Reactions n = 48	Disperse Blue 0.150 mg/cm2 Irritant Reactions n = 48	Negative Control Irritant Reactions n = 48	Disperse Blue 0.017 mg/cm2 Doubtful Reactions n = 48	Disperse Blue 0.050 mg/cm2 Doubtful Reactions n = 48	Disperse Blue 0.150 mg/cm2 Doubtful Reactions n = 48	Negative Control Doubtful Reactions n = 48
Value	16.7 (7.5 to 30.2)	18.8 (8.9 to 32.6)	25.0 (13.6 to 39.6)	2.1 (0.1 to 11.1)	75.0 (60.4 to 86.4)	77.1 (62.7 to 88.0)	72.9 (58.2 to 84.7)	91.7 (80.0 to 97.7)	0.0 (0.0 to 7.4)	0.0 (0.0 to 7.4)	0.0 (0.0 to 7.4)	0.0 (0.0 to 7.4)	8.3 (2.3 to 20.0)	4.2 (0.5 to 14.3)	2.1 (0.1 to 11.1)	6.3 (1.3 to 17.2)

Population analysed: All subjects

Primary outcome: Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration

Time frame: Visit 4: 7 days after application. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Disperse Blue 0.017 mg/cm2 Positive Reactions n = 48	Disperse Blue 0.050 mg/cm2 Positive Reactions n = 48	Disperse Blue 0.150 mg/cm2 Positive Reactions n = 48	Negative Control Positive Reactions n = 48	Disperse Blue 0.017 Negative Reactions n = 48	Disperse Blue 0.050 mg/cm2 Negative Reactions n = 48	Disperse Blue 0.150 mg/cm2 Negative Reactions n = 48	Negative Control Negative Reactions n = 48	Disperse Blue 0.017 mg/cm2 Irritant Reactions n = 48	Disperse Blue 0.050 mg/cm2 Irritant Reactions n = 48	Disperse Blue 0.150 mg/cm2 Irritant Reactions n = 48	Negative Control Irritant Reactions n = 48	Disperse Blue 0.017 mg/cm2 Doubtful Reactions n = 48	Disperse Blue 0.050 mg/cm2 Doubtful Reactions n = 48	Disperse Blue 0.150 mg/cm2 Doubtful Reactions n = 48	Negative Control Doubtful Reactions n = 48
Value	18.8 (8.9 to 32.6)	18.8 (8.9 to 32.6)	27.1 (15.3 to 41.8)	0.0 (0.0 to 7.4)	75.0 (60.4 to 86.4)	72.9 (58.2 to 84.7)	70.8 (55.9 to 83.0)	97.9 (88.9 to 99.9)	0.0 (0.0 to 7.4)	0.0 (0.0 to 7.4)	0.0 (0.0 to 7.4)	0.0 (0.0 to 7.4)	6.3 (1.3 to 17.2)	8.3 (2.3 to 20.0)	2.1 (0.1 to 11.1)	2.1 (0.1 to 11.1)

Primary outcome: Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration

Time frame: Visit 3: 3 days after application. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Bronopol 0.1 mg/cm2 Positive Reactions n = 47	Bronopol 0.250 mg/cm2 Positive Reactions n = 47	Bronopol 0.500 mg/cm2 Positive Reactions n = 47	Bronopol 0.750 mg/cm2 Positive Reactions n = 47	Bronopol 0.1 Negative Reactions n = 47	Bronopol 0.250 mg/cm2 Negative Reactions n = 47	Bronopol 0.500 mg/cm2 Negative Reactions n = 47	Bronopol 0.750 mg/cm2 Negative Reactions n = 47	Bronopol 0.1 mg/cm2 Irritant Reactions n = 47	Bronopol 0.250 mg/cm2 Irritant Reactions n = 47	Bronopol 0.500 mg/cm2 Irritant Reactions n = 47	Bronopol 0.750 mg/cm2 Irritant Reactions n = 47	Bronopol 0.1 mg/cm2 Doubtful Reactions n = 47	Bronopol 0.250 mg/cm2 Doubtful Reactions n = 47	Bronopol 0.500 mg/cm2 Doubtful Reactions n = 47	Bronopol 0.750 mg/cm2 Doubtful Reactions n = 47
Value	14.6 (6.1 to 27.8)	14.6 (6.1 to 27.8)	25.0 (13.6 to 39.6)	45.8 (31.4 to 60.8)	79.2 (65.0 to 89.5)	72.9 (58.2 to 84.7)	58.3 (43.2 to 72.4)	37.5 (24.0 to 52.6)	0.0 (0.0 to 7.4)	0.0 (0.0 to 7.4)	2.1 (0.1 to 11.1)	0.0 (0.0 to 7.4)	6.3 (1.3 to 17.2)	12.5 (4.7 to 25.2)	14.6 (6.1 to 27.8)	16.7 (7.5 to 30.2)

Population analysed: Data from one subject not included because subject did not have a past positive response to either allergen.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 through Day 21. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	0 of 48 (0%)	2 of 48 (4.2%)	Not reported

Limitations and caveats (from the sponsor): There were no limitations or caveats which led to unreadable or uninterpretable data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Contact Dermatitis

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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.

Evy Paulsen, M.D., Ph.D principal investigator

Odense University Hospital

Joseph Fowler, MD principal investigator

Dermatology Specialists PSC

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens in people with Contact Dermatitis, run by Allerderm at 2 sites in 2 countries.

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 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 9 Apr 2018). 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?

Diagnostic Performance: Optimal Test Allergen Concentration (time frame: Visits 3-5: 3-21 days after application). The study lists 6 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 NCT00640250.

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 9 Apr 2018.