Assessment of Suppression of Cutaneous Allergic Responses and Pruritus by Topical Doxycycline

NCT03968562 | Unknown Phase 2 FDA Drug

• 1 other identifier: 1349966
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hives

Outcome Measures

Primary Outcomes (1)

• Change in Mean Allergen Induced Wheal Diameter

  Greatest diameter millimeters and orthogonal diameter millimeters, mean of both

  60 minutes

Study Arms (2)

2% Doxycycline Cream in Generic Aquaphor

ACTIVE COMPARATOR

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

Drug: 2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor

Generic Aquaphor

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.

Drug: 2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor

Interventions

2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor DRUG

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.

2% Doxycycline Cream in Generic Aquaphor; Generic Aquaphor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Conditions

Urticaria

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Rauno O Joks, MD

  State University of New York - Downstate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Division of Allergy Immunology

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 30, 2019
• Study Start: May 15, 2019
• Primary Completion: May 14, 2022
• Study Completion: May 14, 2022
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)