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

Siriraj Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Recalcitrant Alopecia Totalis; Recalcitrant Alopecia Universalis

Treatments: Drug: Botulinum toxin A; Drug: Normal saline injection

Study type: Interventional

Funder types: Other

Identifiers

NCT00997815

SirirajH

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. All patients must be over 18 years old
2. All patients are diagnosed with alopecia totalis or alopecia universalis
3. The alopecia condition was not responded to any treatments

Exclusion criteria

1. Having an active inflammation on scalp area
2. Allergic to botulinum toxin A of human albumin
3. Has been diagnosed with neuromuscular disorders
4. Taking any medication that may interfere with botulinum toxin A action
5. Receiving any treatment for alopecia condition within 4 weeks
6. Pregnant , breastfeeding, plan to pregnant patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Botulinum toxin A

Experimental group

Description:

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.

Treatment:

Drug: Botulinum toxin A

Placebo

Placebo Comparator group

Description:

Using normal saline

Treatment:

Drug: Normal saline injection