| Internal medicines | 1 | ≥2 and ≤6 | all | •The ages of 2 to 6 years old, 54 children with moderate to severe atopic dermatitis diagnosed by the criteria of Haniffin and Rajka were included in the study.•Volunteer children with moderate to severe atopic dermatitis were recruited from the Pediatric Allergy and respiratory Center of the SoonChunHyang University Hospital (Seoul, Korea). At the time of recruitment, written consent was obtained. The ethical committee at the SoonChunHyang University Hospital approved the trial.•Volunteers who agreed by their parents.•The severity of their disease was assessed by modified SCORAD index. |
| 2 | ≥18 | all | •Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.•Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.•Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).•Agree to use emollients daily. |
| 3 | ≥18 | all | •Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months.•Have had inadequate response to existing topical (applied to the skin) medications within 6 months preceding screening.•Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).•Agree to use emollients daily. |
| 4 | ≥18 | all | •Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.•Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.•Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).•Agree to use emollients daily. |
| 5 | ≥12 and ≤75 | all | •Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus•Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis |
| 6 | ≥12 | all | • Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.• Male or female subjects of 12 years of age or older, at the time of informed consent and body weight greater than or equal to 40 kg. Adolescent subjects below the age of 18 years old will only be enrolled in this study if instructed by the sponsor and approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects aged 18 years and older will be enrolled.• Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.• Must have completed the full treatment period of a qualifying Phase 3 study OR must have completed the full rescue treatment period of a qualifying Phase 3 study (if applicable).• Female subjects who are of childbearing potential (which includes all female subjects aged 12 years and older, regardless of whether they have experienced menarche) must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:1.Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization.2.Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.• Female subjects of non childbearing potential must meet at least 1 of the following criteria:1.Have undergone a documented hysterectomy and/or bilateral oophorectomy;2.Have medically confirmed ovarian failure; or3.Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential. |
| 7 | ≥12 | all | • Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.• Must agree to avoid use of prohibited medications throughout the duration of the study. |
| 8 | ≥18 | all | •Male or female subjects aged 18 years or older at the time of informed consent•Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)•Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease.•Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study•Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:1.Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization;2.Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.•Female subjects of non-childbearing potential must meet at least 1 of the following criteria:◦Have undergone a documented hysterectomy and/or bilateral oophorectomy;◦Have medically confirmed ovarian failure; or◦Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.-If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study |
| 9 | ≥19 | all | • Typical clinical manifestations of intermittent or persistent atopic dermatitis for more than 6 months,• If the diagnostic criteria for Hanifin and Rajka are met.• Have been diagnosed with atopic dermatitis from two oriental medical doctors.• Those who have agreed in writing to the clinical trial agreement. |
| Dermatologic Agents | 10 | ≥20 and ≤50 | male | •Healthy male aged from 20 to 50 at screening test•Weight 45kg ~ 90kg with BMI 17kg/m2 ~ 27kg/m2•No skin diseases, no skin damages(scars, tattoo, etc), no hairy skin |
| 11 | ≥19 and≤70 | all | •Male and female patients aged 19 - 70 years.•Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.•Whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).•Who voluntarily agreed to participate in the study and signed an informed consent form. |
| 12 | ≥12 and ≤70 | all | •Male and female patients aged 12 - 70 years.•Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.•Whose affected TBSA is over 5% and below 30%, and IGA score is 2 (mild) to 3 (moderate).•Who voluntarily agreed to participate in the study and signed an informed consent form. |
| 13 | ≥2 and≤12 | all | •Male and female patients aged 24 months - 12 years•Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria, whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).•Who has applied stable amount of emollients daily before baseline visit•Who voluntarily agreed to participate in the study and signed an informed consent form. |
| 14 | ≥5 and≤65 | all | •The diagnosis of AD will be made according to the criteria of Hanifin and Rajka•Age: 5 years to 65 years•objective SCORAD≤40, Diagnosis of Mild to Moderate Atopic Dermatitis (AD)•Exoriation≥1, Lichenification≥1, Dryness≥1 or Exoriation+Lichenification+Dryness≥3•Participants who able to express intention•Participants willing to provide written informed consent |
| 15 | ≥17and ≤64 | all | • (Hanifin and Rajka diagnosis criteria) Those diagnosed with atopic dermatitis• Severity of SCORAD atopic dermatitis Objective index below 40• A person who agrees to participate in the trial after hearing the details of the trial and agrees to observe the notice |
| 16 | ≥12 and ≤18 | all | • Patients suffering from mild to moderate atopic dermatitis |
| 17 | ≥2 and ≤11 | all | • Mild to moderate facial atopic dermatitis• Patients intolerant of, or dependent on, topical corticosteroids |
| Injections | 18 | ≥19 and ≤70 | all | •Of either gender, aged ≥19 and ≤70 years•Atopic dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria•Subacute and chronic atopic subjects who have atopic dermatitis symptoms continually at least 6 months•Subjects with over moderate atopic dermatitis (SCORAD score > 20)•Subjects who understand and voluntarily sign an informed consent form |
| 19 | ≥20 and ≤60 | all | •Of either gender, aged ≥20 and ≤60 years•Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria•subacute and chronic Atopic subjects who have Atopic Dermatitis symptoms continually at least 6 months•Subjects with over moderate atopic dermatitis( SCORAD score > 20 )•Subjects who understand and voluntarily sign an informed consent form |
| 20 | ≥13 | all | •Suitability of autologous blood donation criteria•Current standard medical therapies more than 2 months and moderate-to-severe atopic dermatitis•≥10% lesion body surface area (BSA) of atopic dermatitis involvement in area |
| 21 | ≥19 | all | •Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria•Chronic Atopic Dermatitis that has been present for at least 3 years•EASI>=12 at screening and baseline visit•IGA>=3, SCORAD index>=25, BSA >=10% of AD involvement at screegning and baseline visit•Subjects with documented record of inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks before participating in the study, or whom are inadvisable due to safety risks•Subjects who understand and voluntarily sign an informed consent form |
| 22 | ≥18 | all | •Age 18 and above.•Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.•Diagnosis of AD for ≥1 year.•Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable.•AD involvement of ≥10% body surface area at screening and baseline.•Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation |
| 23 | ≥18 | all | •Participation in a prior clinical trial of dupilumab for AD and met one of the following:1.Received study treatment and adequately completed the assessments required for both the treatment and follow-up periods of the parent studies (except studies listed in b) as defined in the parent protocols2.Received study treatment in one the studies that have completed last patient last visit : R668-AD-0914, R668-AD-1026, R668-AD-1117, R668-AD-1021, R668-AD-1121, and R668-AD-1307 irrespective of duration of participation.3.Underwent screening in R668-AD-1334 (Liberty AD SOLO 1) or R668-AD-1416 (Liberty AD SOLO 2), but could not be randomized due to randomization closure.•Willing and able to comply with all clinic visits and study-related procedures•Able to understand and complete study-related questionnaires•Provide signed informed consent |
| 24 | ≥18 | all | •Chronic AD that had been present for at least 3 years before the screening visit;•Documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of out-patient treatment with topical AD medication(s). |
| 25 | ≥12 | all | •12 years of age or older with a minimum body weight of 40 kg•Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)•Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control |
| 26 | ≥18 | all | • Chronic AD that has been present for at least 3 years before the screening visit;• ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits;• Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks). |
| 27 | ≥18and ≤75 | all | •Subject has provided informed consent prior to initiation of any study specific activities/procedures.•Age greater than or equal to 18 to less than or equal to 75 years at screening.•Clinical diagnosis of chronic AD (also known as atopic eczema) for at least 2 years prior to screening and has confirmed AD (Hanifin and Rajka criteria for AD (Hanifin and Rajka, 1980).•AD that affects greater than or equal to' 10% body surface area as assessed by EASI at screening and on day 1.•An IGA score of greater than or equal to 3 at screening and on day 1.•An EASI score of greater than or equal to 16 at screening and on day 1.•Subject discontinued treatment with TCS, topical calcineurin inhibitors (TCI), prescription moisturizers, or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin for at least the 7 days immediately prior to the first dose of investigational product.•Documented recent history (within 12 months before the screening visit) of inadequate response totreatment with topical TCS or subjects for whom topical treatments are otherwise medically inadvisable (ie, because of important side effects or safety risks).•Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to IGA 0 = clear to IGA 2 = mild) despite treatment with a daily regimen of TCS of medium or higher potency (with or without TCI as appropriate). |
| 28 | ≥19and ≤65 | all | • Patients with atopic dermatitis meeting the Hanifin and Rajka diagnostic criteria• Subacute and chronic patients with symptoms of atopic dermatitis lasting at least 6 months• Patients with moderate to severe atopic dermatitis (EASI score> 7)• Patients who are unable to use conventional therapy due to lack of improvement with conventional treatment methods or concerns about potential side effects• For those who are pregnant, those who are negative during the screening pregnancy test and who consent to contraception during the period of clinical trials• Patients who have voluntarily agreed in writing to participate in the trial |