Cutaneous reaction to off labeled butulinum toxin A and Dysport

comparision of intradermal test of off labeled butulinum toxin A and Dysport

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201503131906N5

Enrollment

100

Registered

2016-01-17

Start date

2014-09-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Allergic reaction to off labelled botulinium toxin A. Hypersensitivity tocorrect drug or medicament properly administered

Interventions

Intervention 1: Intradermal injection of 0.05 ml of off labeled BTX A(2 iu of total 100 iu per vial) on the proximal part of left forearm. skin biopsy from site of positive intradermal test. Elisa tes

Diagnosis

Treatment - Drugs

Intradermal injection of 0.05 ml of off labeled BTX A(2 iu of total 100 iu per vial) on the proximal part of left forearm. skin biopsy from site of positive intradermal test. Elisa test on patients

Intradermal injection of 0.05 ml of Dysport(10 iu of total 500 iu per vial) on the proximal part of right forearm. skin biopsy from site of positive intradermal test. Elisa test on patients serum for

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: inclusion criteri:patients older than 18 ;observation of erythema,edema and/or ecchymosis at all injection sites ;patients with dynamic facial wrinkle ; exclusion criteria:pregnancy ;lactation ;patients with neuromascular junction disorders ;patients with unstable medical condition such as diabetes hypertension ;heart surgery ;history of hypersensitivity to BTA or other component in the furmula

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Erythema at the intradermal test site. Timepoint: after 20 min and at third,6th,12th and 18th hr after skin testing. Method of measurement: inspectin and palpation and measuring the diameter.;Edema at the intradermal test site. Timepoint: after 20 min and at third,6th,12th and 18th hr after skin testing. Method of measurement: inspectin and palpation and measuring the diameter.;Ecchymosis at the intradermal test site. Timepoint: after 20 min and at third,6th,12th and 18th hr after skin testing. Method of measurement: inspectin and palpation and measuring the diameter.	—

Measure

Time frame

Erythema at the intradermal test site. Timepoint: after 20 min and at third,6th,12th and 18th hr after skin testing. Method of measurement: inspectin and palpation and measuring the diameter.;Edema at the intradermal test site. Timepoint: after 20 min and at third,6th,12th and 18th hr after skin testing. Method of measurement: inspectin and palpation and measuring the diameter.;Ecchymosis at the intradermal test site. Timepoint: after 20 min and at third,6th,12th and 18th hr after skin testing. Method of measurement: inspectin and palpation and measuring the diameter.

—

Secondary

Measure	Time frame
Serum immunologic tests for Ig E or IgG related reactions. Timepoint: after positive skin test and/or on month after first expousure. Method of measurement: Elisa test for Ig E or IgG.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Ebrahimi

Kermanshah University of Medical Sciences

aebrahimi@kums.ac.ir+98 83137275557

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026