Trial Outcomes & Findings for Bioequivalence of Ethylenediamine Dihydrochloride Study (NCT NCT01798589)

Last Updated: 2023-07-28

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

16 participants

Primary outcome timeframe

21 days

Results posted on

2023-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	All Subjects All subjects were patched with 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose), 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and negative controls
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bioequivalence of Ethylenediamine Dihydrochloride Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ethylenediamine Dihydrochloride n=16 Participants 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
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	16 participants n=93 Participants
Past Positive Response to Ethylenediamine	16 participants n=93 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	All Subjects n=15 Participants Subjects were patched with a panel containing 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) vs 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and 2 negative controls
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
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

SECONDARY outcome

Timeframe: Day 7-21

Population: Per protocol population

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)

Outcome measures

Outcome measures
Measure	All Subjects n=15 Participants Subjects were patched with a panel containing 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) vs 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and 2 negative controls
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
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 outcome

Timeframe: Day 3-21

Population: Per protocol population

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.

Outcome measures

Outcome measures
Measure	All Subjects n=15 Participants Subjects were patched with a panel containing 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) vs 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and 2 negative controls
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
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Subjects n=15 Participants Subjects were patched with a panel containing 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) vs 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and 2 negative controls
Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) No Tape Irritation	10 participants
Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) Weak Tape Irritation	5 participants
Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) Moderate Tape Irritation	0 participants
Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) Strong Tape Irritation	0 participants

SECONDARY outcome

Timeframe: Day 2 (48 hours after patch application)

Population: Per protocol

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.

Outcome measures

Outcome measures
Measure	All Subjects n=15 Participants Subjects were patched with a panel containing 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) vs 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and 2 negative controls
Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) No Itching	6 Participants
Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) Weak Itching	4 Participants
Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) Moderate Itching	3 Participants
Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) Strong Itching	2 Participants

SECONDARY outcome

Timeframe: Day 2 (48 hours after application)

Population: Per protocol population

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.

Outcome measures

Outcome measures
Measure	All Subjects n=15 Participants Subjects were patched with a panel containing 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) vs 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and 2 negative controls
Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) No Burning	7 Participants
Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) Weak Burning	6 Participants
Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) Moderate Burning	1 Participants
Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) Strong Burning	1 Participants

Adverse Events

Ethylenediamine Hydrochloride: Adverse Events

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ethylenediamine Hydrochloride: Adverse Events n=16 participants at risk Adverse events reported during clinical trial using investigational products: 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) and 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone)
Immune system disorders Dermatitis, contact	6.2% 1/16 • Number of events 1 • Adverse Event information was collected for 21 days; from patch application at day 0 through the final visit at day 21. Two (2) adverse events (contact dermatitis and post-operative wound infection) were deemed by the Investigator, not related to use of the investigational allergens. The remaining adverse event, seborrhoeic dermatitis, could not be attributed to a single test allergen. Relationship in this case is to the allergen panel as a whole.
Infections and infestations Post operative wound infection	6.2% 1/16 • Number of events 1 • Adverse Event information was collected for 21 days; from patch application at day 0 through the final visit at day 21. Two (2) adverse events (contact dermatitis and post-operative wound infection) were deemed by the Investigator, not related to use of the investigational allergens. The remaining adverse event, seborrhoeic dermatitis, could not be attributed to a single test allergen. Relationship in this case is to the allergen panel as a whole.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	6.2% 1/16 • Number of events 1 • Adverse Event information was collected for 21 days; from patch application at day 0 through the final visit at day 21. Two (2) adverse events (contact dermatitis and post-operative wound infection) were deemed by the Investigator, not related to use of the investigational allergens. The remaining adverse event, seborrhoeic dermatitis, could not be attributed to a single test allergen. Relationship in this case is to the allergen panel as a whole.

Additional Information

Joseph Fowler, MD

Dermatology Specialists

Phone: 502-583-7546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place