Phase 2
N=10
Omalizumab in Severe and Refractory Solar Urticaria
Solar Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT02262130 ↗Enrolled (actual)
10
Serious AEs
20.0%
Results posted
Oct 2018
Primary outcome: Primary: Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting) — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Omalizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centre Hospitalier Universitaire de Besancon
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting) |
2 | — |
| SECONDARY Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6 |
4; 1 | — |
| SECONDARY Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting) |
— | — |
| SECONDARY Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity |
4; 0 | — |
| SECONDARY Proportion of Patients Achieving Clinical Remission of Solar Urticaria |
3; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age > or equal to 18 years,
- Appearance of wheals within 15 min after sun exposure and lasting 10, and
- At least 1 of the following: involvement of the face, per annual eruption, extension of wheals on the non-photoexposed skin, SU triggered by artificial light, SU flares accompanied by bronchospasm or syncope.
- Refractory criteria:
- Resistance to photoprotection with sunscreen with sun protection factor ≥ 50, and
- Resistance to administration of an association of 2 different antihistamines during 3 months or to photodesensitization.
Exclusion Criteria
- Contra indication to omalizumab
- Previous treatment with omalizumab
Data sourced from ClinicalTrials.gov (NCT02262130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.