18 and older, any sex, with Solar Urticaria. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)Primary· 4 weeks after the end of treatment
Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting).
A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.
Group
Value
95% CI
Omalizumab
2
Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6Secondary· 4 and 12 weeks after the end of treatment
Proportion of patients for whom the treatment with omalizumab allowed achieving DLQI \< 6.
The index extends from 0 to 30: 0 - 1 = no effect at all on patient's life / 2 - 5 = small effect on patient's life / 6 - 10 = moderate effect on patient's life / 11 - 20 = very large effect on patient's life / 21 - 30 = extremely large effect on patient's life
4 weeks after the end of treatment
Group
Value
95% CI
Omalizumab
4
12 weeks after the end of treatment
Group
Value
95% CI
Omalizumab
1
Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)Secondary· 12 weeks after the end of treatment
Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting).
A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.
Group
Value
95% CI
Omalizumab
0
Proportion of Patients Achieving 50% Improvement in Solar Urticaria IntensitySecondary· 4 and 12 weeks after the end of treatment
Proportion of patients achieving 50% improvement in solar urticaria intensity, compared to baseline, assessed by Visual Analogic Scale (scale extending from 0 to 10)
4 weeks after the end of treatment
Group
Value
95% CI
Omalizumab
4
12 weeks after the end of treatment
Group
Value
95% CI
Omalizumab
0
Proportion of Patients Achieving Clinical Remission of Solar UrticariaSecondary· 4 and 12 weeks after the end of treatment
Proportion of patients showing no or less clinical signs or solar urticaria compared to baseline, under experimental conditions
4 weeks after the end of treatment
Group
Value
95% CI
Omalizumab
3
12 weeks after the end of treatment
Group
Value
95% CI
Omalizumab
1
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual treatment, leading to a large impact on quality of life. New treatment options are warranted. The investigators aim to test the efficacy and the safety of omalizumab, an anti-IgE antibody recently approved in chronic spontaneous urticaria, in this setting.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Besancon
Last refreshed: 12 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02262130.