Allergic Contact Dermatitis
Conditions
Keywords
ethylenediamine dihydrochloride
Brief summary
The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.
Detailed description
We propose an open, prospective, single-site study to evaluate the bioequivalence of ethylenediamine dihydrochloride in methylcellulose (MC)and polyvinylpyrrolidone (PVP) formulations. Bioequivalence will be determined in minimum of 15 adult subjects, with a clinical history of contact dermatitis and a positive patch test (current or previous) to ethylenediamine (sensitives).
Interventions
DRUGEthylenediamine dihydrochloride allergen patch
1 allergen panel containing 2 allergen and 2 control patches
Sponsors
Allerderm
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 10 years) to ethylenediamine dihydrochloride * 18 years of age or older, otherwise in good health * Female subjects of childbearing potential must consent to a urine pregnancy test; results must be negative for study inclusion. * Informed consent signed and understood by each subject.
Exclusion criteria
* Subjects unable to meet inclusion requirements * Women who are breastfeeding or pregnant * Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area * Systemic treatment during the last 7 days with corticosteroids (equivalent to \> 10 mg prednisone) or other immunosuppressive agents * Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks * Acute dermatitis outbreak or dermatitis on or near the test area on the back * Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity) * Subject participation in clinical trials of investigational drugs, treatments, or devices, other than T.R.U.E. TEST, during this study or 3 weeks prior to inclusion in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | 21 days | Bioequivalence will be calculated using concordance (Cohen's Kappa) between the number of subjects with positive reactions (defined as a score of 1+, 2+ or 3+) to 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) and 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and the number of subjects with negative reactions to 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) and 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Late Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Day 7-21 | Number of subjects with a late reaction, defined as a positive reaction (score of 1+, 2+, 3+) initially appearing at 7-21 days after patch application) |
| Number of Participants With Persistent Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Day 3-21 | Number of subjects with a persistent reaction, defined as a positive reaction (score of 1+, 2+, 3+) initially appearing at one visit and persisting through the following visit. |
| Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Day 2 (48 hours after application) | Skin irritation associated with the adhesive tape (tape irritation) used to secure the test patches was evaluated at Visit 2 (day 2) 20 minutes following panel removal according to the following Tape Adhesion Score Scale: None (no irritation), Weak (faint to definite pink erythema), Moderate (moderate erythema, definite redness), Strong (severe erythema, very intense redness). Entire panel was scored as a whole- individual allergen sites were not scored separately. |
| Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Day 2 (48 hours after patch application) | Subject self-report of itching attributed to the test panels was recorded at Visit 2 (day 2), 20 minutes following panel removal. The following Itching Score Scale was used: None (no itching), Weak (minimal discomfort), Moderate (definite discomfort), Strong (significantly bothersome, possible interference with sleep or daily activity). Entire panel was scored as a whole- individual allergen sites were not scored separately. |
| Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Day 2 (48 hours after application) | Subject self-report of burning attributed to the test panels was recorded at Visit 2 (day 2), 20 minutes following panel removal. The following Burning Score scale was used: None (no burning), Weak (minimal discomfort), Moderate (definite discomfort), Strong (significantly bothersome, possible interference with sleep or daily activity). Entire panel was scored as a whole- individual allergen sites were not scored separately. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ethylenediamine Dihydrochloride Arm type: Experimental Ethylenediamine dihydrochloride in methylcellulose 50 mcg/cm2 Ethylenediamine dihydrochloride in polyvinylpyrrolidone 50 mcg/cm2 Methylcellulose (negative control 1) Polyvinylpyrrolidone (negative control 2)
Ethylenediamine dihydrochloride: 1 allergen panel containing 2 allergen and 2 control patches | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Ethylenediamine Dihydrochloride |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Past Positive Response to Ethylenediamine | 16 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Number of Participants With Positive Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Bioequivalence will be calculated using concordance (Cohen's Kappa) between the number of subjects with positive reactions (defined as a score of 1+, 2+ or 3+) to 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) and 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and the number of subjects with negative reactions to 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) and 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone)
Time frame: 21 days
Population: 16 subjects were enrolled. Data from 1 subject was not used in final analysis due to protocol deviation (out of window evaluation).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Subjects | Number of Participants With Positive Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Positive Reactions Ethylenediamine in MC | 10 Participants |
| All Subjects | Number of Participants With Positive Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Positive Reactions Ethylenediamine in PVP | 11 Participants |
95% CI: [41.6, 90.2]
Secondary
Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Subject self-report of burning attributed to the test panels was recorded at Visit 2 (day 2), 20 minutes following panel removal. The following Burning Score scale was used: None (no burning), Weak (minimal discomfort), Moderate (definite discomfort), Strong (significantly bothersome, possible interference with sleep or daily activity). Entire panel was scored as a whole- individual allergen sites were not scored separately.
Time frame: Day 2 (48 hours after application)
Population: Per protocol population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Subjects | Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | No Burning | 7 Participants |
| All Subjects | Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Weak Burning | 6 Participants |
| All Subjects | Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Moderate Burning | 1 Participants |
| All Subjects | Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Strong Burning | 1 Participants |
Secondary
Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Subject self-report of itching attributed to the test panels was recorded at Visit 2 (day 2), 20 minutes following panel removal. The following Itching Score Scale was used: None (no itching), Weak (minimal discomfort), Moderate (definite discomfort), Strong (significantly bothersome, possible interference with sleep or daily activity). Entire panel was scored as a whole- individual allergen sites were not scored separately.
Time frame: Day 2 (48 hours after patch application)
Population: Per protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Subjects | Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | No Itching | 6 Participants |
| All Subjects | Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Weak Itching | 4 Participants |
| All Subjects | Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Moderate Itching | 3 Participants |
| All Subjects | Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Strong Itching | 2 Participants |
Secondary
Number of Participants With Late Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Number of subjects with a late reaction, defined as a positive reaction (score of 1+, 2+, 3+) initially appearing at 7-21 days after patch application)
Time frame: Day 7-21
Population: Per protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects | Number of Participants With Late Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Late Reactions: Ethylenediamine in MC | 1 participants |
| All Subjects | Number of Participants With Late Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Late Reactions Ethylenediamine in PVP | 1 participants |
Secondary
Number of Participants With Persistent Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Number of subjects with a persistent reaction, defined as a positive reaction (score of 1+, 2+, 3+) initially appearing at one visit and persisting through the following visit.
Time frame: Day 3-21
Population: Per protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects | Number of Participants With Persistent Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Persistent Reactions: Ethylenediamine in MC | 7 participants |
| All Subjects | Number of Participants With Persistent Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Persistent Reactions Ethylenediamine in PVP | 8 participants |
Secondary
Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Skin irritation associated with the adhesive tape (tape irritation) used to secure the test patches was evaluated at Visit 2 (day 2) 20 minutes following panel removal according to the following Tape Adhesion Score Scale: None (no irritation), Weak (faint to definite pink erythema), Moderate (moderate erythema, definite redness), Strong (severe erythema, very intense redness). Entire panel was scored as a whole- individual allergen sites were not scored separately.
Time frame: Day 2 (48 hours after application)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects | Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | No Tape Irritation | 10 participants |
| All Subjects | Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Weak Tape Irritation | 5 participants |
| All Subjects | Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Moderate Tape Irritation | 0 participants |
| All Subjects | Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) | Strong Tape Irritation | 0 participants |