HivesPhase 2NCT03968562
Assessment of Suppression of Cutaneous Allergic Responses and Pruritus by Topical Doxycycline
A Phase 2 study testing 2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor in people with Hives, run by State University of New York - Downstate Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hives
- What is being tested?
- 2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 14 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Downstate Medical Center
Brooklyn, New York, 11203
About this study
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.
Read the 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.
- Conditions
- Hives
- Being tested
- 2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Doxycycline Cream in Generic Aquaphor or Generic AquaphorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: 2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Allergen Induced Wheal Diameter
Greatest diameter millimeters and orthogonal diameter millimeters, mean of both
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start15 May 2019
- Primary completion14 May 2022 (estimated)
- Study completion14 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Downstate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rauno Joks, MD, State University of New York - Downstate Medical Center
- Investigators
- Rauno O Joks, MD, Principal investigator, State University of New York - Downstate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968562
- Sponsor's protocol ID
- 1349966
- Status last verified
- Oct 2021
- First submitted
- 22 May 2019
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Suppression of Cutaneous Allergic Responses and Pruritus by Topical Doxycycline
- ClinicalTrials.gov ID
- NCT03968562
- Acronym / sponsor ID
- 1349966
- Conditions
- Hives
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- State University of New York - Downstate Medical CenterUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 14 May 2022 (estimated)
- Study completion
- 14 May 2022 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 2% Doxycycline Cream in Generic Aquaphor | Active comparator | Drug: 2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor2% 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 | Placebo comparator | Drug: 2% Doxycycline Cream in Generic Aquaphor or Generic AquaphorGeneric 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| 2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor2% 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. | Drug | 2% Doxycycline Cream in Generic Aquaphor, Generic Aquaphor |
Primary outcome
Change in Mean Allergen Induced Wheal Diameter
Time frame: 60 minutes
Greatest diameter millimeters and orthogonal diameter millimeters, mean of both
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No. No plan.
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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.
Rauno O Joks, MD principal investigator
State University of New York - Downstate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor in people with Hives, run by State University of New York - Downstate Medical Center at 1 site in United States.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change in Mean Allergen Induced Wheal Diameter (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2021.