Assessment of Suppression of Cutaneous Allergic Responses... | NCT04202263

Studies
Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline

NCT04202263

Sponsor

State University of New York - Downstate Medical Center

Status

Unknown status

Last Update Posted

Oct 14, 2021Actual

Enrollment

25Estimated

Phase

Phase 2

Conditions

Allergic Rhinitis
Asthma

Interventions

Minocycline Topical
Placebos

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 26, 2019Actual

Primary Completion Date

Sep 25, 2023Estimated

Completion Date

Sep 25, 2023Estimated

First Submitted Date

Nov 4, 2019

First Submission Date that Met QC Criteria

Dec 16, 2019

First Posted Date

Dec 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2021

Last Update Posted Date

Oct 14, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rauno Joks, MD, Chief Division of Allergy Immunology, State University of New York - Downstate Medical CenterPrincipal Investigator

Lead Sponsor

State University of New York - Downstate Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Adults with known respiratory allergy/asthma with known skin test sensitization will undergo repeat skin prick testing at 4 areas of both arms (bilateral forearms, bilateral upper arms). Each site will be challenged with up to three known allergens, saline and histamine controls. Mean wheal diameter after 20 minutes challenge will be determined. This is followed by placement of minocycline cream (0%, 1%, 2%, 3%), placed in randomized fashion at each of 1 of 4 skin test sites. Measurement of subsequent wheal diameter will be done at 30 minutes, 60 minutes and 24 hours.

Detailed Description

In addition, itch assessment at each site will be done at baseline, 30 minutes, 60 minutes and 24 hours using VAS and questionnaire.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo cream without minocycline	Drug: Placebos
Minocycline Arm	Active Comparator	Minocycline cream (1%,2%,3%)	Drug: Minocycline Topical

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Minocycline Topical	Drug	Placement of minocycline cream 0%, 1%, 2% or 3% at one of four identical allergen skin test sites.	Minocycline Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in mean diameter of treatment induced effect on wheal size	Compare mean diameter of placebo associated mean wheal diameter vs. 1%, 2%, and 3% minocycline cream	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Change in itch scores by minocycline 1%, 2%, and 3% vs. placebo	Changes in both visual analogue scale (0 to 100mm, with greater itch being with higher scores) and verbal itch scores (0 to 3, with 0 being no itch and 3 being severe itch) with 1%, 2%,and 3% cream vs, placebo over time.	24 hours.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult ( ages 18-75) outpatients with diagnosis of allergic rhinoconjunctivitis and/or asthma who have previously undergone epicutaneous skin prick testing with detection of at least one allergen positive.

Exclusion Criteria:

Subjects who are 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 who have current uncontrolled asthma.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rauno O Joks	Contact	7182701569		rauno.joks@downstate.edu
Catherine Calacanis	Contact	7182704715		ccalacanis@aol.com

Overall Officials

Name	Affiliation	Role
Rauno O Joks	State University of New York - Downstate Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SUNY Downstate Medical Center	Recruiting	Brooklyn	New York	11203	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065631	Rhinitis, Allergic
D001249	Asthma

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008911	Minocycline

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided