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Glucocorticoids With Antihistamines Versus Antihistamines in Acute Urticaria in Emergency

Glucocorticoids Associated With Antihistamines Versus Antihistamines Randomized Double Blinded for the Management of Acute Urticaria in Emergency

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02565680
Acronym
CAHISU
Enrollment
100
Registered
2015-10-01
Start date
2012-02-29
Completion date
2014-02-28
Last updated
2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Urticaria

Keywords

acute urticaria, glucocorticoids, antihistamines, prurit, itch score, rash

Brief summary

Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before.

Detailed description

Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. Acute urticaria is pruritic and incapacitating for daily life. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before. One group randomized received 40mg of cortancyl and 1 pill of citerizine and another group randomized received 1 pill citerizine and placebo like cortancyl. Pharmacy hospital takes care of randomization. Pruritus evaluated with icth score and rash evaluated with nine rule of Wallace, the patient is evaluated in T0, one hour after and contacted by telephone at J2, J5, J15, J 21 itch score, Wallace extension, observance, side effects are asked him.

Interventions

DRUGplacebo

Xyzall 5mg during 5 days + placebo 40mg during 4 days

DRUGprednisone

Xyzall 5mg during 5 days + prednisone 40mg during 4 days

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adults * urticaria rash no more 24 h duration and no take treatment for urticaria

Exclusion criteria

* patients were presented severe anaphylaxis or taken antihistamines or glucocorticoids within 5 days of arrival at ED, * severe infection * pregnancy * patients BPCO * diabetics * allergy corticosteroids * refusal to comply * participate an other study

Design outcomes

Primary

MeasureTime frameDescription
To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours48 hoursTo compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours using the itch score

Secondary

MeasureTime frameDescription
The frequency of side-effects in either treatment group in 21 days21 daysThe frequency of side-effects in either treatment group in 21 days
Evolution of intensity pruritus, angioedema and rash with nine rule of Wallace21 daysEvolution of intensity pruritus at T0 and T1, J2, J5, J15, J21 and angioedema and rash at T1, J2, J5, J15 and J21 comparing at T0 with nine rule of Wallace
The necessary time to decrease pruritus and rash21 daysThe necessary time to decrease pruritus and rash
Recidive of urticaria21 daysThe recidive of urticaria
The observance treatment21 daysObservance treatment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026