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

Study Overview
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Brief Summary
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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.

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

Conditions
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Recalcitrant Alopecia Totalis, Recalcitrant Alopecia Universalis

Intervention / Treatment
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* Drug: Botulinum toxin A
* Drug: Normal saline injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients must be over 18 years old All patients are diagnosed with alopecia totalis or alopecia universalis The alopecia condition was not responded to any treatments Exclusion Criteria: Having an active inflammation on scalp area Allergic to botulinum toxin A of human albumin Has been diagnosed with neuromuscular disorders Taking any medication that may interfere with botulinum toxin A action Receiving any treatment for alopecia condition within 4 weeks Pregnant , breastfeeding, plan to pregnant patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin A<br>The area of alopecia is splited into experimental and control sides by blocked randomization. Experimental sides injected with botulinum toxin A at 2 units per 0.1 ml of dilution with normal saline entire all area. | Drug: Botulinum toxin A<br>* Concentration at 2 units per 0.1 of normal saline dilution<br>* Other names: Botox;|
| Placebo Comparator: Placebo<br>Using normal saline | Drug: Normal saline injection<br>* Using normal saline 2.5 ml injected in control side<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis after intralesional botulinum toxin A injection |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate any possible side effects of intralesional botulinum toxin A injection for alopecia totalis and alopecia universalis |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recalcitrant, Alopecia totalis, Alopecia universalis, Botulinum toxin A