Atopic Dermatitis
Conditions
Brief summary
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
Detailed description
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
Interventions
DRUGIDP-124 Lotion
IDP-124 Lotion, twice-daily application
IDP-124 Vehicle Lotion, twice-daily application
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female at least 2 years of age and older * Written and verbal informed consent must be obtained; subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit) * Nonimmunocompromized male or female who failed to respond adequately to other topical prescription treatment for AD or for whom those treatments are not advisable * Subjects must be willing to comply with study instructions and return to the clinic for required visits; subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing
Exclusion criteria
* Females who are pregnant, breast feeding, or who wish to become pregnant during the study period * Active cutaneous bacterial or viral infection in any treatment area at Baseline (eg, clinically infected AD) * Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline, which would interfere with evaluations * History of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or ichthyosis (other than ichthyosis vulgaris) * History or presence of: * basal cell carcinoma of skin effectively treated more than 2 years ago * carcinoma of cervix effectively treated more than 5 years ago * immunological deficiencies or diseases, HIV, or serious recurrent infection * clinically significant severe renal insufficiency or severe hepatic disorders * Current or recent serious infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to Clear or Almost Clear | Baseline to Week 6 | Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to Clear or Almost Clear | Baseline to Week 10 | Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores. |
| Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75 | Baseline to Week 10 | EASI 75 is defined as at least a 75% reduction in the Eczema Area Severity Index (EASI) score from Baseline. EASI is composite score based on the evaluated severity of 4 key signs of AD (i.e., erythema, infiltration/papulation, excoriation and lichenification), and the extent of disease in each of the 4 body regions (i.e., head/neck, trunk, upper limbs, and lower limbs). The area of involvement (affected by inflammation, not including dry skin) of each of the 4 body regions is determined and represented by a numeric coded value based on a scale from 0 to 6. The 4 body regions are assessed separately for each sign/symptom, and the average degree of severity of each sign in each of the 4 body parts is assigned a score of 0 (none) to 3 (severe) on a scale that allows half-unit increments. The EASI score ranges from 0 to 72, with higher scores being worse. |
| Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to None or Mild | Baseline to Week 2 | Pruritis was assessed on a 4-point scale with 0 (none) to 3 (severe) and higher scores being worse. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IDP-124 Lotion IDP-124 Lotion, twice-daily application | 216 |
| IDP-124 Vehicle Lotion IDP-124 Vehicle Lotion, twice-daily application | 110 |
| Total | 326 |
Baseline characteristics
| Characteristic | IDP-124 Vehicle Lotion | Total | IDP-124 Lotion |
|---|---|---|---|
| Age, Continuous | 33.1 years STANDARD_DEVIATION 20.46 | 31.8 years STANDARD_DEVIATION 20.28 | 31.2 years STANDARD_DEVIATION 20.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 36 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 103 Participants | 69 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 12 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 59 Participants | 169 Participants | 110 Participants |
| Sex: Female, Male Female | 54 Participants | 176 Participants | 122 Participants |
| Sex: Female, Male Male | 56 Participants | 150 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 216 | 0 / 110 |
| other Total, other adverse events | 0 / 216 | 0 / 110 |
| serious Total, serious adverse events | 2 / 216 | 0 / 110 |
Outcome results
Primary
Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to Clear or Almost Clear
Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.
Time frame: Baseline to Week 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDP-124 Lotion | Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to Clear or Almost Clear | 42.04 percentage of participants |
| IDP-124 Vehicle Lotion | Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to Clear or Almost Clear | 32.73 percentage of participants |
Secondary
Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to None or Mild
Pruritis was assessed on a 4-point scale with 0 (none) to 3 (severe) and higher scores being worse.
Time frame: Baseline to Week 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDP-124 Lotion | Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to None or Mild | Week 1 | 46.19 percentage of participants |
| IDP-124 Lotion | Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to None or Mild | Week 2 | 52.76 percentage of participants |
| IDP-124 Vehicle Lotion | Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to None or Mild | Week 1 | 37.41 percentage of participants |
| IDP-124 Vehicle Lotion | Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to None or Mild | Week 2 | 39.81 percentage of participants |
Secondary
Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to Clear or Almost Clear
Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.
Time frame: Baseline to Week 10
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDP-124 Lotion | Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to Clear or Almost Clear | Week 2 | 18.89 percentage of participants |
| IDP-124 Lotion | Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to Clear or Almost Clear | Week 4 | 28.70 percentage of participants |
| IDP-124 Lotion | Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to Clear or Almost Clear | Week 10 | 31.67 percentage of participants |
| IDP-124 Vehicle Lotion | Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to Clear or Almost Clear | Week 2 | 8.73 percentage of participants |
| IDP-124 Vehicle Lotion | Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to Clear or Almost Clear | Week 4 | 24.91 percentage of participants |
| IDP-124 Vehicle Lotion | Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to Clear or Almost Clear | Week 10 | 29.64 percentage of participants |
Secondary
Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75
EASI 75 is defined as at least a 75% reduction in the Eczema Area Severity Index (EASI) score from Baseline. EASI is composite score based on the evaluated severity of 4 key signs of AD (i.e., erythema, infiltration/papulation, excoriation and lichenification), and the extent of disease in each of the 4 body regions (i.e., head/neck, trunk, upper limbs, and lower limbs). The area of involvement (affected by inflammation, not including dry skin) of each of the 4 body regions is determined and represented by a numeric coded value based on a scale from 0 to 6. The 4 body regions are assessed separately for each sign/symptom, and the average degree of severity of each sign in each of the 4 body parts is assigned a score of 0 (none) to 3 (severe) on a scale that allows half-unit increments. The EASI score ranges from 0 to 72, with higher scores being worse.
Time frame: Baseline to Week 10
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDP-124 Lotion | Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75 | Week 4 | 33.61 percentage of participants |
| IDP-124 Lotion | Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75 | Week 6 | 46.11 percentage of participants |
| IDP-124 Lotion | Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75 | Week 10 | 43.24 percentage of participants |
| IDP-124 Vehicle Lotion | Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75 | Week 4 | 26.18 percentage of participants |
| IDP-124 Vehicle Lotion | Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75 | Week 6 | 37.45 percentage of participants |
| IDP-124 Vehicle Lotion | Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75 | Week 10 | 34.00 percentage of participants |