Trial · NCT04200755
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | LoSCAT target lesion | Baseline to End of Treatment Visit, 24 weeks | Treatment response is assessed using the LoSCAT (Localized Scleroderma Cutaneous Assessment Tool). Target lesion will be assessed at Baseline and End of Treatment. Score reduction by 50% after 24 weeks (End of Treatment Visit V14) compared to Baseline Visit (V1) is defined as treatment response. |
| Secondary | mLoSSI all lesions | Baseline to Follow-Up Visit, 48 weeks | Change in mLoSSI (Localized Scleroderma Skin Activity Index) of all existing lesions during treatment, at End of Treatment Visit and during follow-up |
| Secondary | LoSDI all lesions | Baseline to Follow-Up Visit, 48 weeks | Change in LoSDI (Localized Scleroderma Skin Damage Index) of all existing lesions during treatment, at End of Treatment Visit and during follow-up |
| Secondary | Number of lesions | Baseline to Follow-Up Visit, 48 weeks | Count of all existing non-target and new lesions on the entire integument during treatment, at End of Treatment Visit and during follow-up |
| Secondary | DLQI | Baseline to Follow-Up Visit, 48 weeks | Change in DermatoLogy Quality of life Index (DLQI). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. |
| Secondary | RNAseq | Baseline to End of Treatment Visit, 24 weeks | Gene signature of localized scleroderma after Dupilumab treatment: RNA- seq of tissue biopsies obtained from the lesion (lilac ring, optional: center) before (baseline visit V1) and after treatment (EoT V14) and healthy skin before treatment |
| Secondary | RT-qPCR | Baseline to End of Treatment Visit, 24 weeks | Quantification of change in gene expression of genes identified by RNAseq in tissue of localized scleroderma patients after Dupilumab treatment: RT-qPCR of tissue biopsies obtained from the lesion (lilac ring, optional: center) before (baseline visit V1) and after treatment (End of Treatment Visit V14) and healthy skin before treatment |
| Secondary | Adverse events (AEs) | Baseline to Follow-Up Visit, 48 weeks | Adverse events will be documented throughout the study |
| Secondary | Physical examination | Baseline to Follow-Up Visit, 48 weeks | Physical examination (general appearance including skin, head and throat (head, eyes, ears, nose, and throat), lymph nodes, respiratory, cardiovascular, musculoskeletal, and neurological systems) will be documented throughout the study. |
| Secondary | Body weight | Baseline to Follow-Up Visit, 48 weeks | Body weight will be documented throughout the study. |
| Secondary | Blood pressure | Baseline to Follow-Up Visit, 48 weeks | Blood pressure will be documented throughout the study. |
| Secondary | Pulse rate | Baseline to Follow-Up Visit, 48 weeks | Pulse rate will be documented throughout the study. |
| Secondary | Body temperature | Baseline to Follow-Up Visit, 48 weeks | Body temperature will be documented throughout the study. |
| Secondary | Haematocrit (HcT) | Baseline to Follow-Up Visit, 48 weeks | Haematocrit (HcT) will be documented at End of Treatment Visit and during follow-up |
| Secondary | Haemoglobin | Baseline to Follow-Up Visit, 48 weeks | Haemoglobin (Hgb) will be documented at End of Treatment Visit and during follow-up |
| Secondary | Blood cell count | Baseline to Follow-Up Visit, 48 weeks | Platelet count and differential White blood cell count will be documented at End of Treatment Visit and during follow-up |
| Secondary | Blood Enzymes | Baseline to Follow-Up Visit, 48 weeks | Clinical Chemistry parameters (Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Gamma-glutamyl transferase (GGT), Lactic dehydrogenase (LDH)) will be documented at End of Treatment Visit and during follow-up |
| Secondary | Clinical Chemistry | Baseline to Follow-Up Visit, 48 weeks | Clinical Chemistry parameters (Creatinine) will be documented at End of Treatment Visit and during follow-up |
| Secondary | Anti-nuclear antibodies (ANAs) levels | Baseline to Follow-Up Visit, 48 weeks | Change in anti-nuclear antibodies (ANAs) levels |
| Secondary | Serum cytokine levels | Baseline to Follow-Up Visit, 48 weeks | Change in serum levels of IL-4, IL-5, IL-13, periostin, dipeptidyl peptidase-4 |
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/NCT04200755/registered