Trial Outcomes & Findings for Clinical Evaluation of Lyral® Dose Response Study (NCT NCT02028182)

NCT ID: NCT02028182

Last Updated: 2023-07-28

Results Overview

Subjects were patch tested with one experimental T.R.U.E. Test allergen panel containing 0.40 mg/cm\^2, 0.20 mg/cm\^2, and 0.10 mg/cm\^2 of Lyral® and a negative control and a second panel containing the marketed reference allergen (20 mg of Lyral® 5%, in petrolatum). The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Negative responses are graded no response, doubtful response (faint erythema, no infiltration), or irritant response (patchy erythema, no infiltration). Positive responses are graded 1+ (erythema, infiltration, discrete papules), 2+ (erythema infiltration, papules, discrete vesicles), or 3+ (coalescing vesicles, bullous reaction)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Patch test sites were evaluated at day 3 or 4, day 7 and day 21 following application. Results were assessed by the Investigator following the day 21 visit.

Results posted on

2023-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Positive Reactions, Concordance With Reference Allergen Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm\^2, 0.20 mg/cm\^2 and 0.40 mg/cm\^2) Lyral® and a negative control. A second panel containing 20 mg of the marketed Lyral allergen, 5%, in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Lyral®: T.R.U.E. Test allergen panel containing ascending doses of Lyral (0.10 mg/cm\^2, 0.20 mg/cm\^2 and 0.40 mg/cm\^2) and negative control
Overall Study STARTED	22
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Positive Reactions, Concordance With Reference Allergen Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm\^2, 0.20 mg/cm\^2 and 0.40 mg/cm\^2) Lyral® and a negative control. A second panel containing 20 mg of the marketed Lyral allergen, 5%, in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Lyral®: T.R.U.E. Test allergen panel containing ascending doses of Lyral (0.10 mg/cm\^2, 0.20 mg/cm\^2 and 0.40 mg/cm\^2) and negative control
Overall Study Protocol Violation	2

Baseline Characteristics

Clinical Evaluation of Lyral® Dose Response Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Positive Reactions, Concordance With Reference Allergen n=22 Participants Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm2, 0.20 mg/cm2 and 0.40 mg/cm2) and a negative control. A second panel containing 20 mg of 5%, in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Allergen panel containing ascending doses of Lyral (0.10 mg/cm2, 0.20 mg/cm2 and 0.40 mg/cm2) and negative control
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	49.6 years STANDARD_DEVIATION 11.78 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment Denmark	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Patch test sites were evaluated at day 3 or 4, day 7 and day 21 following application. Results were assessed by the Investigator following the day 21 visit.

Outcome measures

Outcome measures
Measure	Positive Reactions, Concordance With Reference Allergen n=20 Participants Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm\^2, 0.20 mg/cm\^2 and 0.40 mg/cm\^2) Lyral® and a negative control. A second panel containing 20 mg of the marketed Lyral allergen, 5%, in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Lyral®: T.R.U.E. Test allergen panel containing ascending doses of Lyral (0.10 mg/cm\^2, 0.20 mg/cm\^2 and 0.40 mg/cm\^2) and negative control
Number of Participants With Positive Patch Test Responses 0.40 mg/cm^2 Lyral Positive Responses	14 participants
Number of Participants With Positive Patch Test Responses 0.20 mg/cm^2 Lyral Positive Responses	12 participants
Number of Participants With Positive Patch Test Responses 0.10 mg/cm^2 Lyral Positive Responses	11 participants
Number of Participants With Positive Patch Test Responses Negative Control Positive Responses	0 participants
Number of Participants With Positive Patch Test Responses 0.40 mg/cm^2 Lyral Negative Responses	6 participants
Number of Participants With Positive Patch Test Responses 0.20 mg/cm^2 Lyral Negative Responses	8 participants
Number of Participants With Positive Patch Test Responses 0.10 mg/cm^2 Lyral Negative Responses	9 participants
Number of Participants With Positive Patch Test Responses Negative Control Negative Responses	20 participants

SECONDARY outcome

Timeframe: Day 2: 48 hours after application

Tape irritation is graded on a 4 point scale: None (no tape irritation), Weak (faint to definite pink), Moderate (moderate erythema, definite redness) and Strong (severe erythema, very intense redness). Percentage of response will include weak, moderate and strong reactions. Itching and Burning are graded on a 4 point scale: None (no discomfort), Weak (minimal discomfort), Moderate (definite discomfort) and Strong (significantly bothersome, possible interference with sleep or daily activity). Percentage of response will include weak, moderate and strong responses.

Outcome measures

Outcome measures
Measure	Positive Reactions, Concordance With Reference Allergen n=22 Participants Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm\^2, 0.20 mg/cm\^2 and 0.40 mg/cm\^2) Lyral® and a negative control. A second panel containing 20 mg of the marketed Lyral allergen, 5%, in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Lyral®: T.R.U.E. Test allergen panel containing ascending doses of Lyral (0.10 mg/cm\^2, 0.20 mg/cm\^2 and 0.40 mg/cm\^2) and negative control
Number of Subjects With Tape Irritation, Itching and Burning Tape Irritation: None	14 participants
Number of Subjects With Tape Irritation, Itching and Burning Tape Irritation: Weak	8 participants
Number of Subjects With Tape Irritation, Itching and Burning Tape Irritation: Moderate	0 participants
Number of Subjects With Tape Irritation, Itching and Burning Tape Irritation: Strong	0 participants
Number of Subjects With Tape Irritation, Itching and Burning Itching: None	7 participants
Number of Subjects With Tape Irritation, Itching and Burning Itching: Weak	10 participants
Number of Subjects With Tape Irritation, Itching and Burning Itching: Moderate	4 participants
Number of Subjects With Tape Irritation, Itching and Burning Itching: Strong	1 participants
Number of Subjects With Tape Irritation, Itching and Burning Burning: None	17 participants
Number of Subjects With Tape Irritation, Itching and Burning Burning: Weak	3 participants
Number of Subjects With Tape Irritation, Itching and Burning Burning: Moderate	2 participants
Number of Subjects With Tape Irritation, Itching and Burning Burning: Strong	0 participants

SECONDARY outcome

Timeframe: Days 2-21

Late reactions initially occur at 7-21 days after application of the panels Persistent reactions appear at Day 2-4 and persist through Day 7-21

Outcome measures

Outcome measures
Measure	Positive Reactions, Concordance With Reference Allergen n=20 Participants Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm\^2, 0.20 mg/cm\^2 and 0.40 mg/cm\^2) Lyral® and a negative control. A second panel containing 20 mg of the marketed Lyral allergen, 5%, in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Lyral®: T.R.U.E. Test allergen panel containing ascending doses of Lyral (0.10 mg/cm\^2, 0.20 mg/cm\^2 and 0.40 mg/cm\^2) and negative control
Number of Subjects Who Exhibit Late or Persistent Reactions 0.40 mg/cm^2 Late Reactions	1 Participants
Number of Subjects Who Exhibit Late or Persistent Reactions 0.20 mg/cm^2 Late Reactions	1 Participants
Number of Subjects Who Exhibit Late or Persistent Reactions 0.10 mg/cm^2 Late Reactions	2 Participants
Number of Subjects Who Exhibit Late or Persistent Reactions 0.40 mg/cm^2 Persistent Reactions	13 Participants
Number of Subjects Who Exhibit Late or Persistent Reactions 0.20 mg/cm^2 Persistent Reactions	10 Participants
Number of Subjects Who Exhibit Late or Persistent Reactions 0.10 mg/cm^2 Persistent Reactions	7 Participants

Adverse Events

Positive Reactions, Concordance With Reference Allergen

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	Positive Reactions, Concordance With Reference Allergen n=22 participants at risk Subjects were patch tested with an experimental allergen panel containing all doses of Lyral (0.10 mg/cm\^2, 0.20 mg/cm\^2 and 0.40 mg/cm\^2) Lyral® and a negative control. A second panel containing 20 mg of the marketed Lyral allergen, 5%, in petrolatum was applied for evaluation of concordance. It is not possible to discern specific dose relative to adverse events.
Eye disorders Conjunctivitus	4.5% 1/22 • Number of events 1 • Days 2-21
Skin and subcutaneous tissue disorders Pruritus	9.1% 2/22 • Number of events 22 • Days 2-21

Additional Information

Kathryn Shannon

Allerderm(dba) SmartPractice

Phone: 6022250595

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place