Dermatitis, Allergic ContactNCT06574204
Clinical Observations of Pain and Pruritus Induced by Exposure to Allergic Contact Dermatitis Caused by Macrolides
An observational study of Dermatitis, Allergic Contact, run by Affiliated Hospital of Nantong University.
Trial summary
Clinical side effects of macrolides in addition to the common gastrointestinal reactions, recently it has been found that the incidence of local reactions after injection is relatively high, such as pain and itching and local inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Allergic Contact
- What is being tested?
- Erythromycin, Azithromycin and physiological saline
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Dec 2024
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study is conducted in healthy adults aged 18-65 years， and there is no gender restriction for the subjects.
Who may be able to join
- The age range of the subjects is from 18 to 65 years old, and there is no gender restriction for the subjects;
- Male subjects weigh more than 50kg (including 50kg) and female subjects weigh more than 45kg (including 45kg); Body mass index [BMI= weight (kg)/ height (m) 2] is in the range of 19-26 kg/m 2, including the critical value;
- The physical examination, laboratory examination, 12 lead electrocardiogram, chest X-ray (anterior lateral and lateral), and vital sign examination of the subjects are all within normal range or abnormal;
- The subjects' blood routine, blood biochemistry, and urine routine are within the normal range;
Who cannot join
- People have a clinical history of the following diseases (including but not limited to gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematological, psychiatric, renal, liver, bronchial, neurological, immune, lipid metabolism disorders, or known or suspected malignant tumors);
- Patients who experience abnormal bleeding within the first 6 months of screening do not meet the criteria;
- Pregnant and lactating women; Or female urine pregnancy test positive;
- Blood routine, blood biochemistry, and urine routine examination are significantly abnormal;
- Have a history of hospitalization or surgery within 6 months before screening;
- Participate in other drug clinical studies within 3 months before screening;
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- Patients with a history of prescription drug abuse and illicit drug abuse or positive urine drug screening within 6 months before screening;
- A history of alcohol abuse in the 6 months before screening, that is, drinking more than 14 units of alcohol per week (1 single drink =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine);
- During the six months before screening, individuals who smoke more than 10 cigarettes per day or test positive for nicotine in their urine;
- Within the 3 months before screening, individuals consumed more than 1 liter of strong tea, coffee, and/or caffeinated beverages per day;
- Within 3 months before screening, the patient has a history of blood donation or acute blood loss (≥ 400mL)；
- Within 2 weeks before the screening, people use prescription drugs, over-the-counter drugs, traditional Chinese patent medicines, and simple preparations or Chinese herbal medicines;
- People have a history of allergy to any of the components of the test drug (erythromycin, azithromycin, other macrolides or ketolides);
- Any other factors deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Mechanism and Clinical Observations of Pain and Pruritus Induced by Exposure to Allergic Contact Dermatitis Resulting From Macrolides
Clinical side effects of macrolides in addition to the common gastrointestinal reactions, recently it has been found that the incidence of local reactions after injection is relatively high, such as pain and itching and local inflammation. Severe skin reactions include erythema multiforme, acute systemic eruption impetigo, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reactions with eosinophilia and systemic symptoms. The clinical study is a single-center, randomized, open, single-dose trial design. The clinical study plans to enroll 30 subjects to evaluate the incidence and severity of pain and pruritus after a single skin test in healthy subjects. A total of 30 subjects were randomly divided into 2 groups with 15 cases in each group. Erythromycin or azithromycin skin test will be performed on the left hand, and the same amount of normal saline will be injected into the right hand as the control. This clinical observation experiment helps improve the side effects and promotes upgrading macrolide antibiotics during clinical application.
- Conditions
- Dermatitis, Allergic Contact
- Being tested
- Erythromycin, Azithromycin, physiological saline
- Keywords
- Dermatitis, Allergic Contact, azithromycin, erythromycin
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
The researchers injected 30 units of erythromycin into the inner right wrist of the subjects, which is a liquid dosage form.
AzithromycinDrug
The researchers injected 30 units of azithromycin into the inner right wrist of the subjects, which is a liquid dosage form.
physiological salineOther
The researchers injected 10-20 μl of physiological saline into the inner left wrist of the subjects, which is a liquid dosage form.
| Study group | Role | What they receive |
|---|---|---|
| healthy individuals with erythromycin skin test | The researchers injected 30 units of erythromycin into the inner right wrist of the subjects, which is a liquid dosage form. Receives: Drug: Erythromycin | |
| healthy individuals with azithromycin skin test | The researchers injected 30 units of azithromycin into the inner right wrist of the subjects, which is a liquid dosage form. Receives: Drug: Azithromycin | |
| healthy individuals with physiological saline | The researchers injected 10-20 μl of physiological saline into the inner left wrist of the subjects, which is a liquid dosage form. Receives: Other: physiological saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the occurrence of type 1 hypersensitivity reaction
The results are observed within 20 ~ 30 minutes after antigen stimulation. The injection site of the drug is compared with normal saline. The subjects observed whether the injection site of the skin had redness, wind mass and redness, and the time of wind mass bulge and disappearance. Participants are surveyed by questionnaire for the presence and extent of pain and pruritus.
Measured: 20-30 minutes after injection
Determine the occurrence of type 4 hypersensitivity reaction
The results are observed within 48-72 hours after antigen stimulation. The injection site of the drug is compared with normal saline. The subjects observed whether the injection site of the skin had redness, wind mass and redness, and the time of wind mass bulge and disappearance. Participants are surveyed by questionnaire for the presence and extent of pain and pruritus.
Measured: 48-72 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, Allergic ContactStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunzhao Xu, Study director, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574204
- Sponsor's protocol ID
- LCYJ20242026
- Status last verified
- Aug 2024
- First submitted
- 25 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanism and Clinical Observations of Pain and Pruritus Induced by Exposure to Allergic Contact Dermatitis Resulting From Macrolides
- ClinicalTrials.gov ID
- NCT06574204
- Acronym / sponsor ID
- LCYJ20242026
- Conditions
- Dermatitis, Allergic Contact
- Keywords
- Dermatitis, Allergic Contact, azithromycin, erythromycin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Aug 2024 (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.
Clinical side effects of macrolides in addition to the common gastrointestinal reactions, recently it has been found that the incidence of local reactions after injection is relatively high, such as pain and itching and local inflammation. Severe skin reactions include erythema multiforme, acute systemic eruption impetigo, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reactions with eosinophilia and systemic symptoms. The clinical study is a single-center, randomized, open, single-dose trial design. The clinical study plans to enroll 30 subjects to evaluate the incidence and severity of pain and pruritus after a single skin test in healthy subjects. A total of 30 subjects were randomly divided into 2 groups with 15 cases in each group. Erythromycin or azithromycin skin test will be performed on the left hand, and the same amount of normal saline will be injected into the right hand as the control. This clinical observation experiment helps improve the side effects and promotes upgrading macrolide antibiotics during clinical application.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy individuals with erythromycin skin test | – | Drug: ErythromycinThe researchers injected 30 units of erythromycin into the inner right wrist of the subjects, which is a liquid dosage form. |
| healthy individuals with azithromycin skin test | – | Drug: AzithromycinThe researchers injected 30 units of azithromycin into the inner right wrist of the subjects, which is a liquid dosage form. |
| healthy individuals with physiological saline | – | Other: physiological salineThe researchers injected 10-20 μl of physiological saline into the inner left wrist of the subjects, which is a liquid dosage form. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is conducted in healthy adults aged 18-65 years， and there is no gender restriction for the subjects.
Key inclusion criteria (4 listed)
- The age range of the subjects is from 18 to 65 years old, and there is no gender restriction for the subjects;
- Male subjects weigh more than 50kg (including 50kg) and female subjects weigh more than 45kg (including 45kg); Body mass index [BMI= weight (kg)/ height (m) 2] is in the range of 19-26 kg/m 2, including the critical value;
- The physical examination, laboratory examination, 12 lead electrocardiogram, chest X-ray (anterior lateral and lateral), and vital sign examination of the subjects are all within normal range or abnormal;
- The subjects' blood routine, blood biochemistry, and urine routine are within the normal range;
Key exclusion criteria (14 listed)
- People have a clinical history of the following diseases (including but not limited to gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematological, psychiatric, renal, liver, bronchial, neurological, immune, lipid metabolism disorders, or known or suspected malignant tumors);
- Patients who experience abnormal bleeding within the first 6 months of screening do not meet the criteria;
- Pregnant and lactating women; Or female urine pregnancy test positive;
- Blood routine, blood biochemistry, and urine routine examination are significantly abnormal;
- Have a history of hospitalization or surgery within 6 months before screening;
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 |
|---|---|---|
| ErythromycinThe researchers injected 30 units of erythromycin into the inner right wrist of the subjects, which is a liquid dosage form. | Drug | healthy individuals with erythromycin skin test |
| AzithromycinThe researchers injected 30 units of azithromycin into the inner right wrist of the subjects, which is a liquid dosage form. | Drug | healthy individuals with azithromycin skin test |
| physiological salineThe researchers injected 10-20 μl of physiological saline into the inner left wrist of the subjects, which is a liquid dosage form. | Other | healthy individuals with physiological saline |
Primary outcome
Determine the occurrence of type 1 hypersensitivity reaction
Time frame: 20-30 minutes after injection
The results are observed within 20 ~ 30 minutes after antigen stimulation. The injection site of the drug is compared with normal saline. The subjects observed whether the injection site of the skin had redness, wind mass and redness, and the time of wind mass bulge and disappearance. Participants are surveyed by questionnaire for the presence and extent of pain and pruritus.
Determine the occurrence of type 4 hypersensitivity reaction
Time frame: 48-72 hours after injection
The results are observed within 48-72 hours after antigen stimulation. The injection site of the drug is compared with normal saline. The subjects observed whether the injection site of the skin had redness, wind mass and redness, and the time of wind mass bulge and disappearance. Participants are surveyed by questionnaire for the presence and extent of pain and pruritus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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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.
Yunzhao Xu study director
Affiliated Hospital of Nantong University
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, Allergic Contact, run by Affiliated Hospital of Nantong University.
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 4 inclusion and 14 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 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Yunzhao Xu (0086-13814606776, xuyz@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the occurrence of type 1 hypersensitivity reaction (time frame: 20-30 minutes after injection). The study lists 2 primary outcomes in all. 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 27 Aug 2024.