Assessment of Suppression of Cutaneous Allergic Responses and Pruritus by Topical Doxycycline
Primary Purpose
Hives
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor
Sponsored by
About this trial
This is an interventional treatment trial for Hives
Eligibility Criteria
Inclusion Criteria:
- Adult (ages 18-75) outpatients with diagnosis of allergic rhino-conjunctivitis and/or asthma who have previously undergone epicutaneous skin prick testing with detection of at least one allergen positive, and who may or may not have had a serum IgE level done as part of their routine evaluation.
Exclusion Criteria:
- Subjects unable/unwilling to undergo cessation of oral antihistamines for five days prior to testing.
- Current use of oral steroids or other systemic immunosuppressants, including omalizumab (anti-IgE therapy) and anti-IL-5 therapy.
- Allergic asthmatics with current uncontrolled asthma.
- Pregnant women
Sites / Locations
- SUNY Downstate Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
2% Doxycycline Cream in Generic Aquaphor
Generic Aquaphor
Arm Description
2% Doxycycline Cream in Generic Aquaphor will be applied topically twice during the study visit: first for 30 minutes, then for 6 hours duration. Will perform concurrent to Placebo Comparator
Generic Aquaphor will be applied topically twice during the study visit: first for 30 minutes, then for 6 hours duration. Will perform concurrent to Active Comparator.
Outcomes
Primary Outcome Measures
Change in Mean Allergen Induced Wheal Diameter
Greatest diameter millimeters and orthogonal diameter millimeters, mean of both
Secondary Outcome Measures
Full Information
NCT ID
NCT03968562
First Posted
May 22, 2019
Last Updated
October 13, 2021
Sponsor
State University of New York - Downstate Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03968562
Brief Title
Assessment of Suppression of Cutaneous Allergic Responses and Pruritus by Topical Doxycycline
Official Title
Assessment of Suppression of Cutaneous Allergic Responses and Pruritus by Topical Doxycycline
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
May 14, 2022 (Anticipated)
Study Completion Date
May 14, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Downstate Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigators will study the effects of topical doxycycline on cutaneous allergic early and late phase responses by determining allergen skin responses in each subject after a single application to allergen induced allergic swelling of 2% doxycycline in emollient.
Detailed Description
This study is a cross-sectional survey to be completed in a single consecutive two day study visit.
To assess the effect of topical doxycycline 2% emollient cream or control emollient on immediate hypersensitivity allergy skin tests responses, pruritus, and associated late phase skin swelling.
Investigators will use generic Aquaphor, a skin protectant, as the control emollient. The active ingredient in this cream is Petrolatum 42%. Inactive ingredients include ceresin, lanolin alcohol, microcrystalline wax, mineral oil, phenoxyethanol.
Adults (ages 18-75 yrs) treated at the SUNY Downstate/UHB Allergy Faculty Practice with known respiratory (allergic rhinoconjunctivitis and/or asthma), and who have previously been evaluated and are allergen skin prick test (SPT) positive to common aeroallergens will, after five days of non-use of oral antihistamine therapy, undergo limited repeat SPT with the same documented positive allergens (up to 5 allergens per subject).
Allergen skin prick testing (Dermapik method) will be done on the volar surface of each forearm, with identical SPT allergens. The profile to be tested will be individualized, from 1-5- allergens, to be determined by previous skin test positive results. Volunteers for the study who have not been previously tested will also be eligible, provided they have a history of symptoms consistent with allergic rhinoconjunctivitis and/or asthma. These subjects will receive testing with a select panel of 5 mixed allergens - to include both perennial (cat, dust mite) and seasonal (tree, grass, ragweed).
Each subject will also be tested with standardized negative and positive controls of saline and histamine. Two control sites, left and right mid upper back, will both be pricked with histamine and saline.
After 20 minutes, the initial baseline determination of mean diameter (average of widest and its orthogonal measurement) will be taken of both wheal and flare, as will itch scores for each arm and each back control site (VAS (0 to 100 mm line) and verbal rating scale ( 0 - none, 1 - mild, 2 - moderate, 4 - severe)).
The location (right versus left) of placement of medication (active) versus control will be determined by a random numbers list for both forearm and back evaluation test sites. The subject will be blinded as to identity of the cream applied at each site.
Using a single blind approach, a thin film of either doxycycline 2% cream or control emollient will be placed on entire test surface of either arm for an additional 30 min then removed. Repeat skin and itch measurements will immediately be done.
After an additional 30 minutes after wiping off the cream repeat skin and itch measurements will be done.
Reapplication - Investigators will then apply repeat film of cream to allergen test surface sites only then send the subject home with instructions to not wash the sites off for 6 hrs.
Repeat measurements at 24 hours post initial removal of cream.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hives
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This cross-sectional survey involves a single consecutive two day study visit.To assess the effect of topical doxycycline 2% emollient cream or control emollient on immediate hypersensitivity allergy skin tests responses, pruritus, and associated late phase skin swelling. We will use generic Aquaphor, a skin protectant, as the control emollient. The active ingredient in this cream is Petrolatum 42%. Inactive ingredients include ceresin, lanolin alcohol, microcrystalline wax, mineral oil, phenoxyethanol. Adults (18-75 yrs) with known respiratory (allergic rhinoconjunctivitis and/or asthma), and are allergen skin prick test (SPT) positive to common aeroallergens will, after 5 days of non-use of oral antihistamine therapy, undergo limited repeat SPT with the same allergens (up to 5 allergens per subject) with measurement of swelling, flare, and itch at 20 min, then after application of doxycycline cream or control emollient, at 30 min, 60 min, and 24 hrs post initial cream removal.
Masking
Participant
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2% Doxycycline Cream in Generic Aquaphor
Arm Type
Active Comparator
Arm Description
2% Doxycycline Cream in Generic Aquaphor will be applied topically twice during the study visit: first for 30 minutes, then for 6 hours duration. Will perform concurrent to Placebo Comparator
Arm Title
Generic Aquaphor
Arm Type
Placebo Comparator
Arm Description
Generic Aquaphor will be applied topically twice during the study visit: first for 30 minutes, then for 6 hours duration. Will perform concurrent to Active Comparator.
Intervention Type
Drug
Intervention Name(s)
2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor
Intervention Description
2% Doxycline Cream in Generic Aquaphor or Generic Aquaphor will be applied topically twice during the study visit: first for 30 minutes, then for 6 hours duration.
Primary Outcome Measure Information:
Title
Change in Mean Allergen Induced Wheal Diameter
Description
Greatest diameter millimeters and orthogonal diameter millimeters, mean of both
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult (ages 18-75) outpatients with diagnosis of allergic rhino-conjunctivitis and/or asthma who have previously undergone epicutaneous skin prick testing with detection of at least one allergen positive, and who may or may not have had a serum IgE level done as part of their routine evaluation.
Exclusion Criteria:
Subjects unable/unwilling to undergo cessation of oral antihistamines for five days prior to testing.
Current use of oral steroids or other systemic immunosuppressants, including omalizumab (anti-IgE therapy) and anti-IL-5 therapy.
Allergic asthmatics with current uncontrolled asthma.
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rauno O Joks, MD
Organizational Affiliation
State University of New York - Downstate Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan.
Learn more about this trial
Assessment of Suppression of Cutaneous Allergic Responses and Pruritus by Topical Doxycycline
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