Trial · NCT07904546
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Eczema Area and Severity Index(EASI) score | At registry inclusion (week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through 60 months. | Atopic dermatititis severity will be assessed by the physician using the Eczema Area and Severity Index (EASI).The score ranges from 0 to 72 ,with higher scores indicating greater disease severity. |
| Primary | Dermatology Life Quality Index (DLQI) score | At registry inclusion (week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through 60 months;an additional visit during weeks 0-4 may occur optionally. | Quality of life will be assessed using the 10 -item Dermatology Life Quality Index.(DLQ),referring to the previous week.Total score ranges from 0 to 30 ;Higher scores indicates greater impairement of quality of life. |
| Secondary | Physician-reported clinical phenotype and affected body sites | At inclusion;phenotype and disease course updated as needed.Body -site involvement assessed at registry inclusion (week 0) at weeks 16,28,and 52 ,then every 24 weeks through months 60. | Clinical phenotype and affected body sites are documented by the physician using the online eCRF, including disease course, clinical subtype, and current eczematous involvement of predefined anatomical areas. |
| Secondary | Atopic Dermatitis-related Pain Intensity | At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60. | Pain intensity during 24 hours,rated by the patient on a 0-10 scale (0=no pain;10=worst imaginable pain).Higher scores indicate more pain. |
| Secondary | Physician-reported Adverse Events During Routine Care | At weeks 16,28, and 52, then every 24 weeks through month 60,and at unscheduled visits when applicable. | Adverse events are documented by treating physicians in the online electronic case report form (eCRF) during routine care. Results will be reported as the number and percentage of participants with at least one documented adverse event;event type and severity will be reported when available. |
| Secondary | Physician/Investigator Global Assessment( PGA/IGA). | At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60. | Atopic dermatitis severity is assessed by the physician using the Physician /Investigator Global Assessment (PGA/IGA).Scores range from 0 to 5 :0=clear,1=almost clear,2=mild,3=moderate,4=severe, and 5 =very severe.Higher scores indicate greater disease severity. |
| Secondary | Sleep impairment | At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60. | Atopic dermatitis-related sleep impairment during the previous night,rated by the patient on a 0-10 scale (0=no impairment;10=extreme impairment).Higher scores indicate greater impairment. |
| Secondary | Patient-assessed atopic dermatitis severity | At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60. | Current disease severity reported by the patient as clear,almost clear,mild,moderate ,severe,or very severe. |
| Secondary | Patient-reported disease control | At weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60. | Number of weeks during the previous 12 weeks in which atopic dermatitits was well controlled,reported by the patient(0-12 weeks). |
| Secondary | Patient satisfaction with treatment | At weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60. | Patient satisfaction with medical care and atopic dermatitis treatment during the previous 3 months,rated on a 0-10 scale(0=very dissatisfied,10=very satisfied). |
| Secondary | Atopic Dermatitis-related Itch Intensity | At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60. | Patient-reported worst itch intensity due to atopic dermatitis during the previous 24 hours,measured on an 11-point numeric rating scale from 0(no itch) to 10 (worst imaginable itch).Higher scores indicate greater itch intensity. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07904546/registered