Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.
Brief Title
A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Completion Date
Completion Date Type
Actual
Conditions
ATOPIC DERMATITIS
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 12 to \< 18 years at Day 1.
* Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria \[Eichenfield et al, 2014\]) that has been present for at least 12 months before signing of informed consent.
* Body weight ≥ 40 kg at screening.
* History of inadequate response to TCS of medium to higher potency (with or without TCI).
* EASI score ≥ 12 at initial screening.
* EASI score ≥ 16 at Day 1.
* vIGA-AD score ≥ 3.
* ≥10% body surface area of AD involvement.
* Worst pruritus NRS ≥ 4.
Exclusion Criteria:
* Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1.
* Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
1. Systemic corticosteroids
2. Non-biologic, non-targeted systemic immunosuppressants
3. Phototherapy
4. Oral or Topical Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
1. TCS of any potency
2. TCI
3. Topical phosphodiesterase 4 inhibitors
4. Other topical immunosuppressive agents
* Age ≥ 12 to \< 18 years at Day 1.
* Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria \[Eichenfield et al, 2014\]) that has been present for at least 12 months before signing of informed consent.
* Body weight ≥ 40 kg at screening.
* History of inadequate response to TCS of medium to higher potency (with or without TCI).
* EASI score ≥ 12 at initial screening.
* EASI score ≥ 16 at Day 1.
* vIGA-AD score ≥ 3.
* ≥10% body surface area of AD involvement.
* Worst pruritus NRS ≥ 4.
Exclusion Criteria:
* Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1.
* Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
1. Systemic corticosteroids
2. Non-biologic, non-targeted systemic immunosuppressants
3. Phototherapy
4. Oral or Topical Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
1. TCS of any potency
2. TCI
3. Topical phosphodiesterase 4 inhibitors
4. Other topical immunosuppressive agents
Inclusion Criteria
Inclusion Criteria:
* Age ≥ 12 to \< 18 years at Day 1.
* Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria \[Eichenfield et al, 2014\]) that has been present for at least 12 months before signing of informed consent.
* Body weight ≥ 40 kg at screening.
* History of inadequate response to TCS of medium to higher potency (with or without TCI).
* EASI score ≥ 12 at initial screening.
* EASI score ≥ 16 at Day 1.
* vIGA-AD score ≥ 3.
* ≥10% body surface area of AD involvement.
* Worst pruritus NRS ≥ 4.
* Age ≥ 12 to \< 18 years at Day 1.
* Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria \[Eichenfield et al, 2014\]) that has been present for at least 12 months before signing of informed consent.
* Body weight ≥ 40 kg at screening.
* History of inadequate response to TCS of medium to higher potency (with or without TCI).
* EASI score ≥ 12 at initial screening.
* EASI score ≥ 16 at Day 1.
* vIGA-AD score ≥ 3.
* ≥10% body surface area of AD involvement.
* Worst pruritus NRS ≥ 4.
Gender
All
Gender Based
false
Keywords
Atopic Dermatitis
AMG 451
KHK4083
Rocatinlimab
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
12 Years
NCT Id
NCT05704738
Org Class
Industry
Org Full Name
Amgen
Org Study Id
20210145
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Re-randomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)
Primary Outcomes
Outcome Description
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Measure
Number of Participants Who Achieved vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
Outcome Time Frame
Baseline and Week 24
Outcome Description
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Measure
Number of Participants Who Achieved EASI 75 at Week 24
Outcome Time Frame
Baseline and Week 24
Secondary Ids
Secondary Id
2022-501586-50
Secondary Outcomes
Outcome Description
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 16
Outcome Measure
Number of Participants Who Achieved EASI 75 at Week 16
Outcome Description
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 16
Outcome Measure
Number of Participants Who Achieved vIGA-AD 0/1 at Week 16
Outcome Description
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 16
Outcome Measure
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Outcome Description
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Number of Participants Who Achieved vIGA-AD 0/1 at Week 24
Outcome Description
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Outcome Description
The EASI was designed by modifying the Psoriasis Area and Severity Index, widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Outcome Description
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Outcome Description
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
Outcome Time Frame
Up to Week 16
Outcome Measure
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 16
Outcome Description
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
Outcome Time Frame
Up to Week 24
Outcome Measure
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 24
Outcome Description
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward \[WOCF\]) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
Outcome Time Frame
Baseline and Week 16
Outcome Measure
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Outcome Description
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Outcome Description
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Outcome Time Frame
Baseline and Week 16
Outcome Measure
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Outcome Description
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Change From Baseline in SCORAD Itch VAS Score at Week 24
Outcome Description
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease. The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Number of Participants ≥ 16 Years Old at Enrollment Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
Outcome Description
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease. The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Change From Baseline in DLQI Score at Week 24 For Participants ≥ 16 Years Old at Enrollment
Outcome Description
The CDLQI was a 10-item questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of child patients suffering from skin disease. The CDLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 24 For Participants < 16 Years Old at Enrollment
Outcome Description
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
Outcome Description
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Change From Baseline in POEM Score at Week 24
Outcome Description
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 16
Outcome Measure
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Outcome Description
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Outcome Description
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
Outcome Time Frame
Baseline and Week 16
Outcome Measure
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Outcome Description
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Outcome Description
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 16
Outcome Measure
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Outcome Description
Average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours. Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance. Participants were asked to rate the intensity of their sleep disturbance using this scale each day. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in level of sleep disturbance.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Outcome Description
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
Outcome Description
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
Outcome Description
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the anxiety.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Outcome Description
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the depression.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Change From Baseline in HADS-depression Subscale Score at Week 24
Outcome Description
The SCORAD total score used to assess the severity of AD using both physician and patient-reported data. SCORAD total score ranged from 0 to 103 with a higher score indicating more severe AD. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Holly Kanavy
Investigator Email
HKanavy@montefiore.org
Investigator Phone
866-633-8255 / 718-230-2997 / 510-996-0741
Categories Mesh Debug
Skin/Dermatology --- DERMATITIS
Immune System --- IMMUNE SYSTEM DISEASES
MeSH Terms
DERMATITIS, ATOPIC
SKIN DISEASES, GENETIC
GENETIC DISEASES, INBORN
CONGENITAL, HEREDITARY, AND NEONATAL DISEASES AND ABNORMALITIES
DERMATITIS
SKIN DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES
SKIN DISEASES, ECZEMATOUS
HYPERSENSITIVITY, IMMEDIATE
HYPERSENSITIVITY
IMMUNE SYSTEM DISEASES