Trial · NCT07266402
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete response to provocation testing at Week 12 | From Day 1 (first dose) to Week 12 | Proportion of Cold Induced Urticaria \[ColdU\] participants with complete response in Critical Temperature Threshold (CTT) or proportion of Symptomatic Dermographism \[SD\] participants with complete response in Critical Friction Threshold at Week 12. * For ColdU patients, a complete response is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest® * For SD patients, a complete response test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest® |
| Secondary | Complete response to provocation testing at Week 24 for Cold Induced Urticaria participants | From Day 1 (first dose) to Week 24 | Proportion of Cold Induced Urticaria participants with complete response in Critical Temperature Threshold (CTT) following the TempTest® 4.0 at Week 24. |
| Secondary | Complete response to provocation testing at Week 24 for Symptomatic Dermographism | From Day 1 (first dose) to Week 24 | Proportion of Symptomatic Dermographism participants with complete response in Critical Friction Threshold (CFT) following the FricTest® 4.0 at Week 24. Temperature Threshold (CTT) following the TempTest® 4.0 at Week 24. |
| Secondary | Improvement in clinical symptoms of itch at Week 12 | From Day 1 (first dose) to Week 12 | Change from baseline in worst itch-numerical rating scale (WI-NRS) at Week 12 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10). |
| Secondary | Improvement in clinical symptoms of itch at Week 24 | From Day 1 (first dose) to Week 24 | Change from baseline in worst itch-numerical rating scale (WI-NRS) at Week 24 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10). |
| Secondary | Improvement in clinical symptoms of itch following provocation testing (WI-NRSprovo) at Week 12 | From Day 1 (first dose) to Week 12 | Change from baseline in WI-NRSprovo at Week 12 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10). |
| Secondary | Complete response to provocation testing at Week 4 | From Day 1 (first dose) to Week 4 | Proportion of Cold Induced Urticaria participants with complete response in Critical Temperature Threshold (CTT) following the TempTest® 4.0 at Week 4 or proportion of Symptomatic Dermographism participants with complete response in Critical Friction Threshold (CFT) following the FricTest® 4.0 at Week 4 |
| Secondary | Improvement in clinical symptoms of hives at Week 12 | From Day 1 (first dose) to Week 12 | Change from baseline in worst hives-numerical rating scale (WH-NRS) at Week 12 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10). |
| Secondary | Improvement in clinical symptoms of hives at Week 24 | From Day 1 (first dose) to Week 24 | Change from baseline in worst hives-numerical rating scale (WH-NRS) at Week 24 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10). |
| Secondary | Change from baseline in Critical Temperature Threshold (CTT) at Week 12 | From Day 1 (first dose) to Week 12 | For participants with Cold Induced Urticaria, change from baseline in CTT following the TempTest® at Week 12. CTT is defined as threshold temperature at which wheals are triggered (highest temperature for cold), assessed at the 10-minute mark. |
| Secondary | Change from baseline in Critical Friction Threshold (CFT) at Week 12 | From Day 1 (first dose) to Week 12 | For participants with Symptomatic Dermographism, change from baseline in CFT following the FricTest® at Week 12. CFT is the threshold pin number at which wheals are triggered, assessed at the 10-minute mark. |
| Secondary | Change from baseline in Critical Temperature Threshold (CTT) at Week 24 | From Day 1 (first dose) to Week 24 | For participants with Cold Induced Urticaria, change from baseline in CTT following the TempTest® at Week 24. |
| Secondary | Change from baseline in Critical Friction Threshold (CFT) at Week 24 | From Day 1 (first dose) to Week 24 | For participants with Symptomatic Dermographism, change from baseline in CFT following the FricTest® at Week 24. |
| Secondary | Change from baseline in Critical Temperature Threshold (CTT) at Week 4 | From Day 1 (first dose) to Week 4 | For participants with Cold Induced Urticaria, change from baseline in CTT following the TempTest® at Week 4. |
| Secondary | Change from baseline in Critical Friction Threshold (CFT) at Week 4 | From Day 1 (first dose) to Week 4 | For participants with Symptomatic Dermographism, change from baseline in CFT following the FricTest® at Week 4. |
| Secondary | Improvement in Dermatology Quality of Life Index (DLQI) at Week 12 | From Day 1 (first dose) to Week 12 | Proportion of participants with DLQI = 0-1 at Week 12. |
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
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GET https://conductscience.org/api/trials/v1/NCT07266402/registered