NCT00997815

The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Siriraj Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine the efficacy of intralesional botulinum toxin type A injection for recalcitrant alopecia totalis and alopecia universalis. Treatments of recalcitrant alopecia totalis and universalis remains an challenge issue for medical practice.The application of diphenylcyclopropenone (DPCP) is still being an standard treatment for the condition, however, there are at least thirty percentage of patients recalcitrant to this treatment. The complete etiology of this disease has yet to be clear.Nevertheless,recent studies have demonstrated the hypothesis of neurotransmitter involvements. There is numerous evidence in support of an imbalance of transmitters, including substance P and Calcitonin gene-related peptide. Botulinum toxin A injection has been used to treat a neuralgiform headache and diffused alopecia areata. Both headache and hair loss have been made much in improvement. This data may support the neurotransmitter imbalance theory. The investigators have been informed about possible effects to the alopecia condition, therefore, this study is conducted to assess the efficacy of botulinum toxin A as the novel treatment for recalcitrant alopecia totalis and alopecia universalis.

Conditions

• Recalcitrant Alopecia Totalis
• Recalcitrant Alopecia Universalis

Interventions

Type	Name	Description
DRUG	Botulinum toxin A	Concentration at 2 units per 0.1 of normal saline dilution
DRUG	Normal saline injection	Using normal saline 2.5 ml injected in control side

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-12-01
• Completion: 2011-06-01
• First posted: 2009-10-19
• Last updated: 2012-08-02

Locations

1 site across 1 country: Thailand