TREAT

TRANSDERMAL RELIEF EVALUATION ALLERGY TOPICALS

T.R.E.A.T.

Transdermal Relief: Evaluating Allergy Topicals

Clarity Research and Consulting, LLC (Clarity) is conducting an

IRB-approved clinical observational study to evaluate patients
experiences and/or perceptions of prescribed topical allergy
medications to treat seasonal allergy medications and perennial
symptoms.

Overview

Research Administer Clarity is the TREAT Study research

administrator.

Study Medications All medications observed in the study are

dispensed by a licensed and approved specialty pharmacy.

Regular Surveys Patients (Participants) regularly complete and

submit surveys to clarity: monthly or quarterly. Up to 18 in total.

Validated Tools Participant perceptions of the prescribed study

medications are evaluated using validated assessment tools: the
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ),
Rhinoconjunctivitis Total Symptom Score (RTSS), and Quality of Life
(QoL) assessment for allergic rhinitis.

Length of Study Up to 3 years.

Study Participants: Inclusion/Exclusion

Criteria

For patients who have tried, failed, or refused Subcutaneous

Immunotherapy (SCIT)

Males or Female. Ages 6 to 64

Provides informed consent to participate and signed HIPAA

disclosure

Participants must have insurance coverage for prescribed

medications

No federally funded insurance Participants

No use of drug of abuse (illicit and/or prescription)

Transdermal Immunotherapy
Potential Benefits

May be effective for rhinitis and urticarial

Rapid absorption to achieve therapeutic dose

May be used for multiple diagnoses

May reduce or eliminate use of oral antihistamines and other

prescription allergy treatments

May reduce or avoid side effects associated with oral

antihistamines

Combines multiple antigens in one medication

Allergy Therapy Treatment Phases

Phase

1 Antihistamine : 1 to 3 months

Phase

2 Allergen Immunotherapy : Build-Up

6 months

Phase

3 Allergen Immunotherapy:
Maintenance approx. 2 years

Visit 1(Baseline) Screening and

Enrollment

Identify potential participant

Obtain informed consent

IRB Consent & HIPAA

Confirm eligibility

Physician to preform ENT examination to determine medically necessary

Preform allergy blood/or skin testing ***

Enroll subject in study

Using Inclusion/Exclusion Criteria

Physician completes Antihistamine Prescription (TT2) & LMN

Collect Survey data

Visit 1: Documentation

Transdermal Antihistamine Cream Prescription (TT2)

Epi-Pen Rx to local Pharmacy

Letter of Medical Necessity

Participant Prescription Insurance Card

Participant Contact Approval Form

Informed Consent

HIPAA

Baseline Survey

Things to Know
*** Preforming allergy blood/or skin testing on first visit is strongly
recommended. If time in office doesnt allow for this to be an option
the testing must be completed and results back within 30 days.

We can not order the immunotherapy without the results of the

testing.

Asking the patient what they are allergic to does not qualify them
for the prescription. They must be tested!

Prescription must be completed by Physician and not an RCC.

Visit 2 Follow Up Survey

This visit is to be completed 30 days after patient starts the

antihistamine formulation

Patient will have an onsite visit

Using the results of the participants allergy blood/or skin test the
physician will complete prescription for the necessary allergens
to be treated.

Complete both Allergen Immunotherapy Prescription (TT2A) and

Topical Allergen Immunotherapy Prescription (TT2B).

Collect survey data

Document any changes to medical history and/or adverse events.

Visit 2: Documents

Allergy Blood/Skin Test

Follow up Survey 2

Visit 3: Follow Up Survey

Collect survey data

Document any medical history and/or adverse events

Schedule Allergen application visit with patient.

Visit 3: Documentation

Follow Up Survey 3

Epi-Pen Confirmation

Schedule Allergen application visit.

Allergen Application Visit

For the first 6 months while the patient is on the immunotherapy

their medication will be sent to the investigators office. Each
month they receive higher dose of the allergens so they must be
monitored by the clinical staff.

Clinical staff will watch the participant apply each dosage then
patient will need to wait 20-30 minutes to ensure no anaphylactic
issues arise.

Must have patients allergens onsite as well as their epi-pen.

Participant will sign Anaphylaxis Information consent form and

must be kept in their clinic chart.

Clinical staff will review with participant on how to use the dosage
logs.