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. 2019 Apr 26;2019(4):CD004055. doi: 10.1002/14651858.CD004055.pub2

PACTR201704002194318.

Trial name or title Assessment of botulinum toxin type A in the treatment of hand eczema
Methods Randomised double‐blind placebo‐controlled parallel‐group study
Participants 60 patients with hand eczema
Inclusion criteria
  • Active symptomatic palmar hand eczema 

  • Bilateral involvement

  • 18 to 70 years of age


Exclusion criteria
  • Skin infection at the site of injection 

  • History of use of botulinum toxin in the last 4 months

  • Pregnancy, lactation in females

  • Any contraindication to botulinum toxin injection including associated disorder that may affect neuromuscular function, like myasthenia gravis and Lambert‐Eaton disease

  • History of previous allergy to BTXA

Interventions Intervention:
• Intradermal palmar injection of a minimum of 50 units of botulinum toxin type A combined with topical corticosteroids
• Topical betamethasone twice daily
Outcomes Primary outcome of the trial
  • Visual linear analogue scale of pruritus at baseline at the third day, end of first week, fourth week, then monthly for a whole period of 6 months


Secondary outcomes of the trial
  • Hand eczema severity index at baseline at third day, end of first week, fourth week, then monthly for a whole period of 6 months

Starting date 2017‐04‐15
Contact information Carmen Amin
El Areesh Street, No. 2, Smouha, 3rd floor
#302 21646
Alexandria
Egypt
002‐01222966670
carmen271173@yahoo.com
Notes Sponsor: Dermatology Department, Faculty of Medicine, University of Alexandria

BTXA: botulinum toxin A.

DLQI: Dermatology Life Quality Index.

ECG: electrocardiogram.

EQ‐5D: standardised index for measuring quality of life by the EuroQol in 5 dimensions.

HECSI: hand eczema severity index.

mTLSS: modified total lesion symptom score.

PaGA: participants' global assessment.

PBI‐HE: patient benefit index for chronic hand eczema.

PeDeSi: Person‐Centered Dermatology Self‐Care Index.

PGA: physicians' global assessment.

PUVA: (topical and oral) psoralen combined with UVA.

QALY: quality‐adjusted life‐year.

TLSS: total lesion symptom score.

UVB: ultraviolet B.